Cleared Traditional

MODIFICATION TO API UNISCEPT 20GP

K901559 · Analytical Products, Inc. · Microbiology
Sep 1990
Decision
160d
Days
Class 1
Risk

About This 510(k) Submission

K901559 is an FDA 510(k) clearance for the MODIFICATION TO API UNISCEPT 20GP, a Gram Positive Identification Panel (Class I — General Controls, product code LQL), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on September 10, 1990, 160 days after receiving the submission on April 3, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K901559 FDA.gov
FDA Decision Cleared SESE
Date Received April 03, 1990
Decision Date September 10, 1990
Days to Decision 160 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

Similar Devices — LQL Gram Positive Identification Panel

All 10
GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP90
K972576 · Accumed Intl., Inc. · Jan 1998
RAPID GRAM-POSITIVE ID SYSTEM
K961730 · Becton Dickinson Microbiology Systems · Feb 1997
BBLCRYSTAL GRAM-POSITIVE ID SYSTEM
K961968 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1997
VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)
K952095 · Biomerieux Vitek, Inc. · Mar 1996
VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD
K925916 · Biomerieux Vitek, Inc. · Mar 1993
RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA
K910304 · Vitek Systems, Inc. · Jul 1991