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FDA 510(k)

COMPLEMENT C3 NEPHELOMETRIC ASSAY

K-Number: K801363 · 1980-06-30

ApplicantJ.T. Baker Chemical Co.
Decision Date1980-06-30
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

COMPLEMENT C3 NEPHELOMETRIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1980-06-30 under 510(k) number K801363. The device is classified under product code CZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPLEMENT C3 NEPHELOMETRIC ASSAY?

COMPLEMENT C3 NEPHELOMETRIC ASSAY is a medical device that received FDA 510(k) clearance on 1980-06-30. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K801363.

When did COMPLEMENT C3 NEPHELOMETRIC ASSAY receive FDA 510(k) clearance?

COMPLEMENT C3 NEPHELOMETRIC ASSAY received FDA 510(k) clearance on 1980-06-30, under 510(k) number K801363.

Who is the listed applicant for COMPLEMENT C3 NEPHELOMETRIC ASSAY?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMPLEMENT C3 NEPHELOMETRIC ASSAY?

The FDA product code for COMPLEMENT C3 NEPHELOMETRIC ASSAY is CZW.

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Other records listing J.T. Baker Chemical Co. 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.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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Related Devices (Code: CZW)

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.

K100179SPAPLUSThe Binding Site Group , Ltd.K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OYK061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.K050665N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)Dade Behring, Inc.K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical DiagnosticsK032796IBL C3D-CIC EIA TESTIbl GmbH

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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