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FDA 510(k)

FACTOR DEFICIENT SUBSTRATE PLASMA VIII

K-Number: K840928 · 1984-04-30

ApplicantDiatech, Inc.
Decision Date1984-04-30
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FACTOR DEFICIENT SUBSTRATE PLASMA VIII is the device name listed in this FDA 510(k) record. The listed applicant is Diatech, Inc.. It received FDA 510(k) clearance on 1984-04-30 under 510(k) number K840928. 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 FACTOR DEFICIENT SUBSTRATE PLASMA VIII?

FACTOR DEFICIENT SUBSTRATE PLASMA VIII is a medical device that received FDA 510(k) clearance on 1984-04-30. The listed applicant is Diatech, Inc.. The 510(k) number is K840928.

When did FACTOR DEFICIENT SUBSTRATE PLASMA VIII receive FDA 510(k) clearance?

FACTOR DEFICIENT SUBSTRATE PLASMA VIII received FDA 510(k) clearance on 1984-04-30, under 510(k) number K840928.

Who is the listed applicant for FACTOR DEFICIENT SUBSTRATE PLASMA VIII?

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

What is the FDA product code for FACTOR DEFICIENT SUBSTRATE PLASMA VIII?

The FDA product code for FACTOR DEFICIENT SUBSTRATE PLASMA VIII is GGP.

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Other records listing Diatech, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881685FIBRINOGENTEST-OK854938COASCREENER/DIASCREENERBLOOD PLASMA TIMING INST.K854089DIATIMER-1 BLOOD PLASMA CLOT TIMING INSTRUMENTK854090DIATIMER-2 BLOOD PLASMA CLOT TIMING INSTRUMENTK842286DIA T1, T2 & T3K841365DIA REPTIN

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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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