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FDA 510(k)

COAGULASE PLASMA, HORSE & RABBIT EDTA

K-Number: K833858 · 1983-12-08

ApplicantOtisville Biotech, Inc.
Decision Date1983-12-08
Product CodeJTL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COAGULASE PLASMA, HORSE & RABBIT EDTA is the device name listed in this FDA 510(k) record. The listed applicant is Otisville Biotech, Inc.. It received FDA 510(k) clearance on 1983-12-08 under 510(k) number K833858. 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, HORSE & RABBIT EDTA?

COAGULASE PLASMA, HORSE & RABBIT EDTA is a medical device that received FDA 510(k) clearance on 1983-12-08. The listed applicant is Otisville Biotech, Inc.. The 510(k) number is K833858.

When did COAGULASE PLASMA, HORSE & RABBIT EDTA receive FDA 510(k) clearance?

COAGULASE PLASMA, HORSE & RABBIT EDTA received FDA 510(k) clearance on 1983-12-08, under 510(k) number K833858.

Who is the listed applicant for COAGULASE PLASMA, HORSE & RABBIT EDTA?

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

What is the FDA product code for COAGULASE PLASMA, HORSE & RABBIT EDTA?

The FDA product code for COAGULASE PLASMA, HORSE & RABBIT EDTA is JTL.

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Other records listing Otisville Biotech, Inc. as applicant

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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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