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FDA 510(k)

COAGULASE PLASMA

K-Number: K820177 · 1982-02-05

ApplicantQuadroma, Inc.
Decision Date1982-02-05
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 Quadroma, Inc.. It received FDA 510(k) clearance on 1982-02-05 under 510(k) number K820177. 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 1982-02-05. The listed applicant is Quadroma, Inc.. The 510(k) number is K820177.

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

COAGULASE PLASMA received FDA 510(k) clearance on 1982-02-05, under 510(k) number K820177.

Who is the listed applicant for COAGULASE PLASMA?

The FDA 510(k) record lists Quadroma, Inc. 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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