Cleared Traditional

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET

K872360 · American Dade · Hematology
Jul 1987
Decision
18d
Days
Class 2
Risk

About This 510(k) Submission

K872360 is an FDA 510(k) clearance for the DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by American Dade (Santa Ana, US). The FDA issued a Cleared decision on July 6, 1987, 18 days after receiving the submission on June 18, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K872360 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1987
Decision Date July 06, 1987
Days to Decision 18 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GHH — Fibrin Split Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

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