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FDA 510(k)

STACHROM ANTIPLASMIN TEST KIT

K-Number: K882602 · 1988-09-02

ApplicantAmerican Bioproducts Co.
Decision Date1988-09-02
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STACHROM ANTIPLASMIN TEST 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 1988-09-02 under 510(k) number K882602. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STACHROM ANTIPLASMIN TEST KIT?

STACHROM ANTIPLASMIN TEST KIT is a medical device that received FDA 510(k) clearance on 1988-09-02. The listed applicant is American Bioproducts Co.. The 510(k) number is K882602.

When did STACHROM ANTIPLASMIN TEST KIT receive FDA 510(k) clearance?

STACHROM ANTIPLASMIN TEST KIT received FDA 510(k) clearance on 1988-09-02, under 510(k) number K882602.

Who is the listed applicant for STACHROM ANTIPLASMIN TEST 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 STACHROM ANTIPLASMIN TEST KIT?

The FDA product code for STACHROM ANTIPLASMIN TEST KIT is GGP.

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Other records listing American Bioproducts Co. as applicant

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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.

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