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FDA 510(k)

RABBIT COAGULASE PLASMA

K-Number: K812602 · 1981-09-29

ApplicantDutchland Laboratories, Inc.
Decision Date1981-09-29
Product CodeJTL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RABBIT COAGULASE PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Dutchland Laboratories, Inc.. It received FDA 510(k) clearance on 1981-09-29 under 510(k) number K812602. 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 COAGULASE PLASMA?

RABBIT COAGULASE PLASMA is a medical device that received FDA 510(k) clearance on 1981-09-29. The listed applicant is Dutchland Laboratories, Inc.. The 510(k) number is K812602.

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

RABBIT COAGULASE PLASMA received FDA 510(k) clearance on 1981-09-29, under 510(k) number K812602.

Who is the listed applicant for RABBIT COAGULASE PLASMA?

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

What is the FDA product code for RABBIT COAGULASE PLASMA?

The FDA product code for RABBIT COAGULASE PLASMA is JTL.

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Related Devices (Code: JTL)

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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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