Cleared Traditional

GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90

K972576 · Accumed Intl., Inc. · Microbiology
Jan 1998
Decision
196d
Days
Class 1
Risk

About This 510(k) Submission

K972576 is an FDA 510(k) clearance for the GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90, a Gram Positive Identification Panel (Class I — General Controls, product code LQL), submitted by Accumed Intl., Inc. (Westlake, US). The FDA issued a Cleared decision on January 22, 1998, 196 days after receiving the submission on July 10, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K972576 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 1997
Decision Date January 22, 1998
Days to Decision 196 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LQL — Gram Positive Identification Panel
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

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