Cleared Traditional

KINETIC FIBRINOGEN ASSAY

K881150 · Bio/Data Corp. · Hematology
Mar 1988
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K881150 is an FDA 510(k) clearance for the KINETIC FIBRINOGEN ASSAY, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on March 28, 1988, 11 days after receiving the submission on March 17, 1988. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K881150 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 1988
Decision Date March 28, 1988
Days to Decision 11 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GIS — Test, Fibrinogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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