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FDA 510(k)

STAPHASE*

K-Number: K811982 · 1981-07-28

ApplicantAnalytical Products, Inc.
Decision Date1981-07-28
Product CodeJTL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

STAPHASE* 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 1981-07-28 under 510(k) number K811982. 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 STAPHASE*?

STAPHASE* is a medical device that received FDA 510(k) clearance on 1981-07-28. The listed applicant is Analytical Products, Inc.. The 510(k) number is K811982.

When did STAPHASE* receive FDA 510(k) clearance?

STAPHASE* received FDA 510(k) clearance on 1981-07-28, under 510(k) number K811982.

Who is the listed applicant for STAPHASE*?

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 STAPHASE*?

The FDA product code for STAPHASE* is JTL.

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Other records listing Analytical Products, Inc. as applicant

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K924814API 20E/UNISCEPT 20EK923684API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MICK922926API UNISCEPT KB/TYPE 2 AND 3K901559MODIFICATION TO API UNISCEPT 20GPK901390DMAC INDOLE REAGENTK895796API UNISCEPT KB

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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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