Cleared Traditional

THROMBOKINETIC FIBRINOGEN ASSAY

K792563 · Bio/Data Corp. · Hematology
Jan 1980
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K792563 is an FDA 510(k) clearance for the THROMBOKINETIC FIBRINOGEN ASSAY, a System, Fibrinogen Determination (Class II — Special Controls, product code KQJ), submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980, 30 days after receiving the submission on December 12, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K792563 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 1979
Decision Date January 11, 1980
Days to Decision 30 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code KQJ — System, Fibrinogen Determination
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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