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FDA 510(k)

QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT

K-Number: K761058 · 1977-02-07

ApplicantBio/Data Corp.
Decision Date1977-02-07
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1977-02-07 under 510(k) number K761058. 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 QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT?

QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT is a medical device that received FDA 510(k) clearance on 1977-02-07. The listed applicant is Bio/Data Corp.. The 510(k) number is K761058.

When did QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT receive FDA 510(k) clearance?

QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT received FDA 510(k) clearance on 1977-02-07, under 510(k) number K761058.

Who is the listed applicant for QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT?

The FDA 510(k) record lists Bio/Data Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT?

The FDA product code for QUAN-8 MULT-COMP FACTOR VIII ASSAY 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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