Cleared Traditional

APTT REAGENT

K904341 · Sigma Chemical Co. · Hematology
Nov 1990
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K904341 is an FDA 510(k) clearance for the APTT REAGENT, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on November 8, 1990, 49 days after receiving the submission on September 20, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K904341 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 1990
Decision Date November 08, 1990
Days to Decision 49 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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