FDA 510(k)

STA-COAG CONTROL [P] PLUS KIT

K-Number: K952338 · 1995-09-21

Decision Date1995-09-21

Product CodeGGC

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

STA-COAG CONTROL [P] PLUS KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1995-09-21 under 510(k) number K952338. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA-COAG CONTROL [P] PLUS KIT?

STA-COAG CONTROL [P] PLUS KIT is a medical device that received FDA 510(k) clearance on 1995-09-21. The listed applicant is American Bioproducts Co.. The 510(k) number is K952338.

When did STA-COAG CONTROL [P] PLUS KIT receive FDA 510(k) clearance?

STA-COAG CONTROL [P] PLUS KIT received FDA 510(k) clearance on 1995-09-21, under 510(k) number K952338.

Who is the listed applicant for STA-COAG CONTROL [P] PLUS KIT?

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

What is the FDA product code for STA-COAG CONTROL [P] PLUS KIT?

The FDA product code for STA-COAG CONTROL [P] PLUS KIT is GGC.

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Related Devices (Code: GGC)

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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.