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FDA 510(k)

ASSERACHROM FREE PROTEIN S KIT

K-Number: K954017 · 1995-11-13

ApplicantAmerican Bioproducts Co.
Decision Date1995-11-13
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ASSERACHROM FREE PROTEIN S 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 1995-11-13 under 510(k) number K954017. 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 ASSERACHROM FREE PROTEIN S KIT?

ASSERACHROM FREE PROTEIN S KIT is a medical device that received FDA 510(k) clearance on 1995-11-13. The listed applicant is American Bioproducts Co.. The 510(k) number is K954017.

When did ASSERACHROM FREE PROTEIN S KIT receive FDA 510(k) clearance?

ASSERACHROM FREE PROTEIN S KIT received FDA 510(k) clearance on 1995-11-13, under 510(k) number K954017.

Who is the listed applicant for ASSERACHROM FREE PROTEIN S 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 ASSERACHROM FREE PROTEIN S KIT?

The FDA product code for ASSERACHROM FREE PROTEIN S KIT is GGP.

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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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