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FDA 510(k)

NEW STACHROM ANTIPLASMIN

K-Number: K921449 · 1992-09-23

ApplicantAmerican Bioproducts Co.
Decision Date1992-09-23
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

NEW STACHROM ANTIPLASMIN 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 1992-09-23 under 510(k) number K921449. 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 NEW STACHROM ANTIPLASMIN?

NEW STACHROM ANTIPLASMIN is a medical device that received FDA 510(k) clearance on 1992-09-23. The listed applicant is American Bioproducts Co.. The 510(k) number is K921449.

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

NEW STACHROM ANTIPLASMIN received FDA 510(k) clearance on 1992-09-23, under 510(k) number K921449.

Who is the listed applicant for NEW STACHROM ANTIPLASMIN?

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 NEW STACHROM ANTIPLASMIN?

The FDA product code for NEW STACHROM ANTIPLASMIN 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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