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FDA 510(k)

API STAPHASE III

K-Number: K833988 · 1983-12-22

ApplicantAnalytical Products, Inc.
Decision Date1983-12-22
Product CodeJTL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

API STAPHASE III is the device name listed in this FDA 510(k) record. The listed applicant is Analytical Products, Inc.. It received FDA 510(k) clearance on 1983-12-22 under 510(k) number K833988. 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 API STAPHASE III?

API STAPHASE III is a medical device that received FDA 510(k) clearance on 1983-12-22. The listed applicant is Analytical Products, Inc.. The 510(k) number is K833988.

When did API STAPHASE III receive FDA 510(k) clearance?

API STAPHASE III received FDA 510(k) clearance on 1983-12-22, under 510(k) number K833988.

Who is the listed applicant for API STAPHASE III?

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

What is the FDA product code for API STAPHASE III?

The FDA product code for API STAPHASE III is JTL.

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Other records listing Analytical Products, 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.K833858COAGULASE PLASMA, HORSE & RABBIT EDTAOtisville Biotech, 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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