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FDA 510(k)

PROTOPATH FACTOR IX ASSAY

K-Number: K834050 · 1984-02-04

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

Device Summary

PROTOPATH FACTOR IX 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 K834050. 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 IX ASSAY?

PROTOPATH FACTOR IX 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 K834050.

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

PROTOPATH FACTOR IX ASSAY received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834050.

Who is the listed applicant for PROTOPATH FACTOR IX 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 IX ASSAY?

The FDA product code for PROTOPATH FACTOR IX ASSAY is GGP.

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Related Devices (Code: 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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