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FDA 510(k)

GOAT ANTI-HUMAN C-REACTIVE PROTEIN

K-Number: K791560 · 1979-09-24

ApplicantProtos Laboratories
Decision Date1979-09-24
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

GOAT ANTI-HUMAN C-REACTIVE PROTEIN is the device name listed in this FDA 510(k) record. The listed applicant is Protos Laboratories. It received FDA 510(k) clearance on 1979-09-24 under 510(k) number K791560. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GOAT ANTI-HUMAN C-REACTIVE PROTEIN?

GOAT ANTI-HUMAN C-REACTIVE PROTEIN is a medical device that received FDA 510(k) clearance on 1979-09-24. The listed applicant is Protos Laboratories. The 510(k) number is K791560.

When did GOAT ANTI-HUMAN C-REACTIVE PROTEIN receive FDA 510(k) clearance?

GOAT ANTI-HUMAN C-REACTIVE PROTEIN received FDA 510(k) clearance on 1979-09-24, under 510(k) number K791560.

Who is the listed applicant for GOAT ANTI-HUMAN C-REACTIVE PROTEIN?

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

What is the FDA product code for GOAT ANTI-HUMAN C-REACTIVE PROTEIN?

The FDA product code for GOAT ANTI-HUMAN C-REACTIVE PROTEIN is DCK.

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Other records listing Protos Laboratories 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.

K802177GOAT ANTI-HUMAN IGMK802196GOAT ANTI-HUMAN COMPLEMENT C4K802257GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFICK791605GOAT ANTI-HUMAN ALPHA-1-ANTITRYPSINK791115GOAR ANTI-HUMAN LAMBODA CHAIN

Related Devices (Code: DCK)

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.

K242170K-ASSAY CRP (Ver.2)Kamiya Biomedical Company, LLCK201256Procise CRP, ProciseDx Analyzer, ProciseDx Calibration CartridgeProcise DiagnosticsK192028Yumizen C1200 CRPHORIBA ABX SASK192118CRP VarioSENTINEL CH. SpAK191993Yumizen C1200 CRPHORIBA ABX SASK160712VITROS Chemistry Products hsCRP ReagentOrtho Clinical Diagnostics

Official Source

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