Cleared Traditional

MICROBIOLOGICAL TRAY READER-MANUAL

K842947 · American Micro Scan · Microbiology
Sep 1984
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K842947 is an FDA 510(k) clearance for the MICROBIOLOGICAL TRAY READER-MANUAL, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by American Micro Scan (Mchenry, US). The FDA issued a Cleared decision on September 14, 1984, 50 days after receiving the submission on July 26, 1984. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K842947 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 1984
Decision Date September 14, 1984
Days to Decision 50 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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