OEM SYSTEMS CO. LTD.

FDA Device Registration & Listing · UJI-SHI Kyoto, JP · Registration 1000487132

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
1000487132
FEI Number
1000487132
Entity Name
OEM SYSTEMS CO. LTD.
City/State/Country
UJI-SHI Kyoto, JP
Establishment Address
84 MEKAWA MAKISHIMA-CHO, UJI-SHI Kyoto 6110041, JP
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
OEM SYSTEMS CO. LTD. (Owner Number: 9050895)
Owner / Operator Contact Address
84 MEKAWA MAKISHIMA-CHO, UJI-SHI KYOTO, JP-NOTA 6110041, JP
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Variant Newborn Hemoglobin Screening System Variant II Turbo Link Variant nbs Newborn Screening System Variant II Hemoglobin System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GKA Abnormal Hemoglobin Quantitation Hematology Class 2 864.7415 2023-01-26
PDJ Hemoglobin A1c Test System Clinical Chemistry Class 2 862.1373 2023-01-26
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection Clinical Chemistry Class 2 862.1675 2023-01-26
GKA Abnormal Hemoglobin Quantitation Hematology Class 2 864.7415 2023-01-26
JPD Hemoglobin A2 Quantitation Hematology Class 2 864.7400 2023-01-26
LCP Assay, Glycosylated Hemoglobin Hematology Class 2 864.7470 2023-01-26

Official Correspondent

Kenneth Block

US Agent Details

Kenneth Block Business: Ken Block Consulting Email: k.block@kenblockconsulting.com Phone: (972) 4809554

Related Public Records

Same Entity

OEM SYSTEMS CO. LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K834595 Beckman Instruments, Inc. PARAGON ACID HEMOGLOBIN REAGENT KIT 1984-05-07
K171771 Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay 2017-12-04
K945777 Smiths Industries Medical Systems, Inc. PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES 1994-12-22
K920820 Helena Laboratories MODIFICATION COLUMNMATE 1992-08-17
K991850 Biosafe Laboratories, Inc. SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC 1999-11-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0030-2014 Perkin Elmer Health Sciences, Inc. 2
Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.
Z-0017-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Reorder Pack; 400 tests; For the determination of Hemoglobin A1c in human whole blood. IVD Contents: 1. Elution Buffer 1 2 x 2000 ml Bio-Tris Phosphate Buffer 2. Elution Buffer 2 1 x 1000 ml Bio-Tris Phosphate Buffer 3. Wash/Diluent 1 x 1600 mL Deionized water 4. Analytical cartridge - 1 cation exchange cartridge 5. Floppy Diskette 1-program parameters 6. Calibrator/Diluent set. 2 levels of calibrator, 3 vial each: lyophylized human blood cell hemolysate with preservative; 1 bottle 100 mL or diluent deionized water. 7. Whole Blood Primer: 4 vials Lyophylized human red blood cells hemolysate with preservative. 8. Sample vials, 100 x 1.5 mL Polypropylene with pierceable lid 9 Thermal paper - 1 roll 10. Instruction manual Made in United States Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0018-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Supplemental Reagent Pack: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0019-2012 Bio-Rad Laboratories, Inc. 2
D-10 Hemoglobin A1c Program Elution Buffer 2: Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)
Z-0020-2012 Bio-Rad Laboratories, Inc. 2
VARIANT II TURBO Hemoglobin A1c Program Reorder Pack, 1600 tests, IVD, Made in United States. Kit contains: 1. Elution Buffer A 3 x 2500 mL, Bis-Tris Phosphate Buffer 2. Elution Buffer B 1 x 1500 mL Bis-Tris Phosphate Buffer 3. Cartridge Set, 2 cation exchange analytical cartridges, 4 cation exchange Guard cartridges. 4. CD-ROM 1 - CD Rom with program parameters 5. Calibration/Diluent set - 2 levels, 2 vial each of lyophilized human red blood cell hemolysate with preservative, 1 bottle diluent, 100 mL deionized water. 6. Whole Blood Primer, 6 x 1 mL, lyophilized human red blood cell hemolysate with preservative, 7. Sample vials - 2 x 100, 1.5 mL polypropylene vials with pierceable caps. 8. Instruction Manual. Bio-Rad Laboratories, Hercules, CA 94547. Percentage determination of hemoglobin A1c in human whole blood using ion-exchange high=performance liquid chromatography (HPLC)

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000487132. Last updated year: 2026. Please use registration number 1000487132 when referencing this establishment in official correspondence.
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