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FDA 510(k)

PROTOPATH FACTOR VIII ASSAY

K-Number: K834051 · 1984-02-04

ApplicantAmerican Dade
Decision Date1984-02-04
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PROTOPATH FACTOR VIII ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834051. 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 PROTOPATH FACTOR VIII ASSAY?

PROTOPATH FACTOR VIII ASSAY is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is American Dade. The 510(k) number is K834051.

When did PROTOPATH FACTOR VIII ASSAY receive FDA 510(k) clearance?

PROTOPATH FACTOR VIII ASSAY received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834051.

Who is the listed applicant for PROTOPATH FACTOR VIII ASSAY?

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

What is the FDA product code for PROTOPATH FACTOR VIII ASSAY?

The FDA product code for PROTOPATH FACTOR VIII ASSAY 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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