Cleared Traditional

ACCUSCAN MICROBEAD STANDARDS

K902294 · Sigma Chemical Co. · Hematology
Jul 1990
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K902294 is an FDA 510(k) clearance for the ACCUSCAN MICROBEAD STANDARDS, a Calibrator, Surrogate (Class II — Special Controls, product code JIW), submitted by Sigma Chemical Co. (St. Louis, US). The FDA issued a Cleared decision on July 3, 1990, 42 days after receiving the submission on May 22, 1990. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number K902294 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1990
Decision Date July 03, 1990
Days to Decision 42 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JIW — Calibrator, Surrogate
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1150

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