CLINICAL DIAGNOSTIC SOLUTIONS, INC.

FDA Device Registration & Listing · PLANTATION, FL, US · Registration 1064130

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1064130
FEI Number
3002684533
Entity Name
CLINICAL DIAGNOSTIC SOLUTIONS, INC.
City/State/Country
PLANTATION, FL, US
Establishment Address
1800 N.W. 65TH AVE., PLANTATION, FL 33313, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
Owner / Operator
Boule Diagnostics AB (Owner Number: 9034165)
Owner / Operator Contact Address
Fagerstagatan 7, Spanga, SE-NOTA SE-163 53, SE
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K041130
PMA Number
N/A

All Registered Proprietary Names

501-475 Quintus 5-Part Lyse Medonic M51-L1 Lyse 501-464 Medonic M-Series Lyse 501-466 Swelab Alfa Lyse Swelab Lumi-L2 Lyse Medonic M51-L2 Lyse Swelab Lumi-L1 Lyse 501-050 CDS SHEATH REAGENT 501-074 Enzymatic Cleaner Concentrate 501-477 Quintus 5-Part Stopper Cell-Dyn Emerald Cleaner 501-002 ENZYMATIC CLEANER 501-205 CDS Rinse Solution 501-350 Quintus 5-Part Stopper 501-036 Boule Cleaning Kit 501-029 Ac.T Cleaner and Shutdown Solution 501-204 CDS Rinse Solution 501-073 CDS DETERGENT REAGENT 501-064 CDS DETERGENT REAGENT 501-032 ENZYMATIC CLEANER 501-063 ENZYMATIC CLEANER CONCENTRATE Boule EasyCleaner 501-066 CDS DETERGENT REAGENT 501-292 Quintus 5-Part Diluent Cell-Dyn Emerald Diluent 501-202 CDS Hematology Diluent Medonic M51-D Diluent 501-057 CDS Hematology Diluent 501-069 CDS HEMATOLOGY DILUENT 501-465 Swelab Alfa Diluent 501-201 CDS Hematology Diluent 501-212 Medonic M-Series Diluent 501-052 CDS Hematology Diluent 501-056 CDS Hematology Diluent 501-081 CDS Diluent Sheath Swelab Lumi-D Diluent 501-128 HEMATOLOGY DILUENT 501-133 CDS KX21 Hematology Diluent 501-067 CDS HEMATOLOGY DILUENT 501-208 Swelab Alfa Diluent 501-463 Medonic M-Series Diluent 501-003 HEMATOLOGY DILUENT 501-476 Quintus 5-Part Diluent

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JPK Mixture, Hematology Quality Control Hematology Class 2 864.8625 2007-11-20
GGK Products, Red-Cell Lysing Products Hematology Class 1 864.8540 1999-06-04
OYE Flow Cytometric Reagents And Accessories. Hematology Class 2 864.5220 2015-08-03
KIP Formulations, Balanced Salt Solutions Hematology Class 1 864.2875 1999-04-08
JCB Detergent Pathology Class 1 864.4010 2015-11-17
GIF Diluent, Blood Cell Hematology Class 1 864.8200 2013-02-13
KRZ Calibrator For Hemoglobin And Hematocrit Measurement Hematology Class 2 864.8165 2007-11-20
KRY Calibrator For Platelet Counting Hematology Class 2 864.8175 2007-11-20
KSA Calibrator For Red-Cell And White-Cell Counting Hematology Class 2 864.8185 2007-11-20

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Boule Diagnostics AB
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3004008703 BOULE MEDICAL AB Spanga Stockholm, SE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K781077 Dade, Baxter Travenol Diagnostics, Inc. CONTROL, HEMATOLOGY, CH-60 1978-07-27
K052101 Roche Diagnostics C.F.A.S. (CALIBRATOR FOR AUTOMATED SYSTEMS) HBA1C 2005-08-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1064130. Last updated year: 2026. Please use registration number 1064130 when referencing this establishment in official correspondence.
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