Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003030793

FEI Number

3003030793

Entity Name

DIAMOND DIAGNOSTICS Inc

City/State/Country

Holliston, MA, US

Establishment Address

333 Fiske St, Holliston, MA 01746, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Diamond Diagnostics Inc. (Owner Number: 10028706)

Owner / Operator Contact Address

333 Fiske St, Holliston, MA 01746, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K121140

PMA Number

N/A

All Registered Proprietary Names

SmartLyte CD Cal-Packs Mission Reagents BK ISE Analyzer Cal-Packs BK BUN Analyzer Dade Calibrator BK Glucose Controls SMARTLYTE® Electrolyte Analyzer OY Reagents Diamond Calibrators for Tokyo Boeki ISE Module Trinity B Automated Test System PROLYTE Packs CALIBRATOR Molecular Analyzer Linearity CONTROL Immunology Calibrator PROLTYE® Electrolyte Analyzer

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2009-02-26
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2009-02-26
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2009-02-26
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2009-02-26
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2009-02-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-02-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-02-26
JIX	Calibrator, Multi-Analyte Mixture	Clinical Chemistry	Class 2	862.1150	2009-02-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2010-09-10
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-02-26
CDS	Electrode, Ion Specific, Urea Nitrogen	Clinical Chemistry	Class 2	862.1770	2009-02-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2010-09-10
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-02-26
CGA	Glucose Oxidase, Glucose	Clinical Chemistry	Class 2	862.1345	2009-02-26
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	Clinical Chemistry	Class 1	862.1660	2009-02-26
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-01-10
JFP	Electrode, Ion Specific, Calcium	Clinical Chemistry	Class 2	862.1145	2013-01-10
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2013-01-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-01-10
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-01-10
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-02-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2013-01-10
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-02-26
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2014-05-01
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2009-02-26
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2009-02-26
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2009-02-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-02-26
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2020-02-12
OOI	Real Time Nucleic Acid Amplification System	Clinical Chemistry	Class 2	862.2570	2024-12-27
NQX	System, Nucleic Acid Amplification Test, Dna, Methicillin Resistant Staphylococcus Aureus, Direct Specimen	Microbiology	Class 2	866.1640	2024-12-27
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2011-11-11
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2009-02-26
JJY	Multi-Analyte Controls, All Kinds (Assayed)	Clinical Chemistry	Class 1	862.1660	2020-02-12
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2024-12-27
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2024-12-27
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2024-12-27
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2024-12-27
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2024-12-27
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2024-12-27
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2024-12-27
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2024-12-27
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2024-12-27
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2024-12-27
JIT	Calibrator, Secondary	Clinical Chemistry	Class 2	862.1150	2009-02-26
CEM	Electrode, Ion Specific, Potassium	Clinical Chemistry	Class 2	862.1600	2013-01-10
JGS	Electrode, Ion Specific, Sodium	Clinical Chemistry	Class 2	862.1665	2013-01-10
JIH	Flame Photometry, Lithium	Clinical Toxicology	Class 2	862.3560	2013-01-10
CGZ	Electrode, Ion-Specific, Chloride	Clinical Chemistry	Class 2	862.1170	2013-01-10

Official Correspondent

Kathy Fisher

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Diamond Diagnostics Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006198300	Diamond Diagnostics Inc.	Budapest, HU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K840557	Shaban Mfg. Co.	REAGENTS & STANDARDS IL 501 NA/K	1984-04-04
K801007	Instrumentation Laboratory CO	IL SYSTEM 502 NA/K ANALYZER	1980-05-14
K811310	Chem-Elec, Inc.	SODIUM/POTASSIUM REAGENT KITS	1981-07-10
K013373	Roche Diagnostics Corp.	OMNI C ANALYZER	2001-11-02
K884771	Instrumentation Laboratory CO	IL PHOENIX, MODEL 900, CHEMISTRY/ELECTROLYTE ANALY	1989-02-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0148-2020	Siemens Healthcare Diagnostics, Inc.	2	Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automated, clinical chemistry analyzer to perform in vitro diagnostic tests on clinical specimens
Z-0139-2011	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimension vista System.
Z-0024-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	FSH Calibrators (LN 9C06-01), for in vitro diagnostic use.
Z-0024-2015	Siemens Healthcare Diagnostics, Inc.	2	Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the calibration of Creatine Kinase MB Isoenzyme (MMB) method on the Dimension Vista System.
Z-0025-2007	Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila	2	Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use.

Similar Registrations

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3012817228	Epocal Inc	Ottawa Ontario, CA
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH
9612296	Beckman Coulter Mishima K.K.	SUNTO-GUN Shizuoka, JP
3006198300	Diamond Diagnostics Inc.	Budapest, HU
9610529	ROCHE DIAGNOSTICS GMBH	PENZBERG Bavaria, DE

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003030793. Last updated year: 2026. Please use registration number 3003030793 when referencing this establishment in official correspondence.