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FDA 510(k)

SPQ TM TEST SYSTEM II FOR CRP

K-Number: K892526 · 1989-05-09

ApplicantAtlantic Antibodies
Decision Date1989-05-09
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SPQ TM TEST SYSTEM II FOR CRP is the device name listed in this FDA 510(k) record. The listed applicant is Atlantic Antibodies. It received FDA 510(k) clearance on 1989-05-09 under 510(k) number K892526. 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 SPQ TM TEST SYSTEM II FOR CRP?

SPQ TM TEST SYSTEM II FOR CRP is a medical device that received FDA 510(k) clearance on 1989-05-09. The listed applicant is Atlantic Antibodies. The 510(k) number is K892526.

When did SPQ TM TEST SYSTEM II FOR CRP receive FDA 510(k) clearance?

SPQ TM TEST SYSTEM II FOR CRP received FDA 510(k) clearance on 1989-05-09, under 510(k) number K892526.

Who is the listed applicant for SPQ TM TEST SYSTEM II FOR CRP?

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

What is the FDA product code for SPQ TM TEST SYSTEM II FOR CRP?

The FDA product code for SPQ TM TEST SYSTEM II FOR CRP is DCK.

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Other records listing Atlantic Antibodies 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.

K891154SPQ(TM) ANTIBODY REAGENT SET II FOR APO A-I/APO BK890563SPQ(TM) ANTIBODY REAGENT SET II FOR TRFK890561SPQ(TM) ANTIBODY REAGENT SET II FOR IGMK890562SPQ(TM) ANTIBODY REAGENT SET II FOR HPTK890416SPQ(TM) ANTIBODY REAGENT SET II FOR IGGK890417SPQ(TM) ANTIBODY REAGENT SET II FOR C3

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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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