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FDA 510(k)

RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122

K-Number: K870945 · 1987-06-10

ApplicantOxoid U.S.A., Inc.
Decision Date1987-06-10
Product CodeJTL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1987-06-10 under 510(k) number K870945. The device is classified under product code JTL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122?

RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 is a medical device that received FDA 510(k) clearance on 1987-06-10. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K870945.

When did RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 receive FDA 510(k) clearance?

RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 received FDA 510(k) clearance on 1987-06-10, under 510(k) number K870945.

Who is the listed applicant for RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122?

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

What is the FDA product code for RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122?

The FDA product code for RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 is JTL.

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Other records listing Oxoid U.S.A., Inc. as applicant

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K891593LISTERIA SELECTIVE ENRICHMENT MEDIUMK884026ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KITK884208LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION)K874303STAPHYLASE TESTK872956SORBITOL MACCONKEY AGAR NO. 3 CM 813K872135MCBRIDE MEDIUM CM 819

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Related Devices (Code: JTL)

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.

K950706DRYSLIDE COAGULASEDifco Laboratories, Inc.K883333RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENTImmuno-Mycologics, Inc.K861312LYFO-KWIK (TM) COAGULASE PLASMAMicro-Bio-LogicsK840553HEMASTAPHRemel Co.K833988API STAPHASE IIIAnalytical Products, Inc.K833858COAGULASE PLASMA, HORSE & RABBIT EDTAOtisville Biotech, Inc.

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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