Cleared Traditional

LOW FIBRINOGEN CONTROL

K812108 · Bio/Data Corp. · Hematology
Sep 1981
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K812108 is an FDA 510(k) clearance for the LOW FIBRINOGEN CONTROL, 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 September 24, 1981, 59 days after receiving the submission on July 27, 1981. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K812108 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 1981
Decision Date September 24, 1981
Days to Decision 59 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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