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FDA 510(k)

MODIFIED CRP LATEX TEST

K-Number: K880016 · 1988-02-25

ApplicantSclavo, Inc.
Decision Date1988-02-25
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MODIFIED CRP LATEX TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1988-02-25 under 510(k) number K880016. 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 MODIFIED CRP LATEX TEST?

MODIFIED CRP LATEX TEST is a medical device that received FDA 510(k) clearance on 1988-02-25. The listed applicant is Sclavo, Inc.. The 510(k) number is K880016.

When did MODIFIED CRP LATEX TEST receive FDA 510(k) clearance?

MODIFIED CRP LATEX TEST received FDA 510(k) clearance on 1988-02-25, under 510(k) number K880016.

Who is the listed applicant for MODIFIED CRP LATEX TEST?

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

What is the FDA product code for MODIFIED CRP LATEX TEST?

The FDA product code for MODIFIED CRP LATEX TEST is DCK.

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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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