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FDA 510(k)

COAGULASE PLASMA

K-Number: K792235 · 1979-12-07

ApplicantRemel Co.
Decision Date1979-12-07
Product CodeJTL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COAGULASE PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1979-12-07 under 510(k) number K792235. 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 COAGULASE PLASMA?

COAGULASE PLASMA is a medical device that received FDA 510(k) clearance on 1979-12-07. The listed applicant is Remel Co.. The 510(k) number is K792235.

When did COAGULASE PLASMA receive FDA 510(k) clearance?

COAGULASE PLASMA received FDA 510(k) clearance on 1979-12-07, under 510(k) number K792235.

Who is the listed applicant for COAGULASE PLASMA?

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

What is the FDA product code for COAGULASE PLASMA?

The FDA product code for COAGULASE PLASMA is JTL.

Related Clinical Trials

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Other records listing Remel Co. 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.

K013711BACTI-SWAB DRYK965151A.C.T. IIIK965150A.C.T. IVK965152A.C.T. IIK965149A.C.T. IK960090CALCOFLUOR WHITE STAIN KIT

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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.K870945RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122Oxoid U.S.A., Inc.K861312LYFO-KWIK (TM) COAGULASE PLASMAMicro-Bio-LogicsK840553HEMASTAPHRemel Co.K833988API STAPHASE IIIAnalytical Products, 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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