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FDA 510(k)

GLYCATED PROTEIN CALIBRATORS

K-Number: K940008 · 1994-05-09

ApplicantPrimus Corp.
Decision Date1994-05-09
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLYCATED PROTEIN CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Primus Corp.. It received FDA 510(k) clearance on 1994-05-09 under 510(k) number K940008. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLYCATED PROTEIN CALIBRATORS?

GLYCATED PROTEIN CALIBRATORS is a medical device that received FDA 510(k) clearance on 1994-05-09. The listed applicant is Primus Corp.. The 510(k) number is K940008.

When did GLYCATED PROTEIN CALIBRATORS receive FDA 510(k) clearance?

GLYCATED PROTEIN CALIBRATORS received FDA 510(k) clearance on 1994-05-09, under 510(k) number K940008.

Who is the listed applicant for GLYCATED PROTEIN CALIBRATORS?

The FDA 510(k) record lists Primus Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLYCATED PROTEIN CALIBRATORS?

The FDA product code for GLYCATED PROTEIN CALIBRATORS is JIS.

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Other records listing Primus Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K062658PRIMUS A1CARE ASSAYK013787NYCOCARD CRPK014084NYCOCARD CRP CONTROLK994045PRIMUS LIQUID CALIBRATOR FOR GHB/A1C LEVEL 1 AND LEVEL 2K992921PRIMUS LIQUID CONTROL FOR GHB/ALC LEVEL I AND LEVEL IIK955283PRIMUS VARIANT SYSTEM PVS99

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Related Devices (Code: JIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories LimitedK061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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