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FDA 510(k)

COAGULASE PLASMA-CITRATED & EDTA

K-Number: K822988 · 1982-11-05

ApplicantAmerican Scientific Products
Decision Date1982-11-05
Product CodeJTL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

COAGULASE PLASMA-CITRATED & EDTA is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1982-11-05 under 510(k) number K822988. 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-CITRATED & EDTA?

COAGULASE PLASMA-CITRATED & EDTA is a medical device that received FDA 510(k) clearance on 1982-11-05. The listed applicant is American Scientific Products. The 510(k) number is K822988.

When did COAGULASE PLASMA-CITRATED & EDTA receive FDA 510(k) clearance?

COAGULASE PLASMA-CITRATED & EDTA received FDA 510(k) clearance on 1982-11-05, under 510(k) number K822988.

Who is the listed applicant for COAGULASE PLASMA-CITRATED & EDTA?

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

What is the FDA product code for COAGULASE PLASMA-CITRATED & EDTA?

The FDA product code for COAGULASE PLASMA-CITRATED & EDTA is JTL.

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Other records listing American Scientific Products 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.

K864824INFECTIOUS TISSUE KITK844042BLOOD DILUTION VIALK831634GLUCOSE REAGENT B6360-11K831625UREA NITROGEN-BUN-REAGENTS B6360-12K831626UREA NITROGEN-BUN-REAGENTS B6370-11AK831628CREATININE REAGENTS B6370-13

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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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