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FDA 510(k)

TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE

K-Number: K853244 · 1985-08-12

ApplicantSimmler, Inc.
Decision Date1985-08-12
Product CodeCEK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1985-08-12 under 510(k) number K853244. The device is classified under product code CEK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE?

TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is Simmler, Inc.. The 510(k) number is K853244.

When did TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE receive FDA 510(k) clearance?

TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE received FDA 510(k) clearance on 1985-08-12, under 510(k) number K853244.

Who is the listed applicant for TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE?

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

What is the FDA product code for TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE?

The FDA product code for TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE is CEK.

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Other records listing Simmler, Inc. as applicant

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K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874820MULTICHEM HDL PRECIPITATING REAGENT #S0914K874812MULTICHEM CHLORIDE REAGENT S0933K874311MULTICHEM (R) TOTAL BILIRUBIN

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Related Devices (Code: CEK)

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.

K992846HICHEM TOTAL PROTEIN REAGENTElan Holdings, Inc.K973108TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50Diagnostic Chemicals , Ltd.K980042CARESIDE TOTAL PROTEINExigent Diagnostics, Inc.K971524TOTAL PROTEIN OR TPCarolina Liquid Chemistries Corp.K961864CSF/URINE TOTAL PROTEINTeco DiagnosticsK955905STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAYSolarcare Technologies Corp,Inc.

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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