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FDA 510(k)

C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT

K-Number: K962049 · 1996-12-18

ApplicantPolymedco, Inc.
Decision Date1996-12-18
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT is the device name listed in this FDA 510(k) record. The listed applicant is Polymedco, Inc.. It received FDA 510(k) clearance on 1996-12-18 under 510(k) number K962049. 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 C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT?

C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT is a medical device that received FDA 510(k) clearance on 1996-12-18. The listed applicant is Polymedco, Inc.. The 510(k) number is K962049.

When did C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT receive FDA 510(k) clearance?

C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT received FDA 510(k) clearance on 1996-12-18, under 510(k) number K962049.

Who is the listed applicant for C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT?

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

What is the FDA product code for C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT?

The FDA product code for C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT is DCK.

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Other records listing Polymedco, Inc. as applicant

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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

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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