LQM · Class I · 21 CFR 866.2660

FDA Product Code LQM: Gram Negative Identification Panel

Leading manufacturers include Pasco Laboratories, Inc., American Micro Scan and Radiometer America, Inc..

7
Total
7
Cleared
129d
Avg days
1985
Since

FDA 510(k) Cleared Gram Negative Identification Panel Devices (Product Code LQM)

7 devices
1–7 of 7
Cleared Apr 05, 1993
ROCHE OXI/FERM II
K923313
Roche Diagnostic Systems, Inc.
Microbiology · 272d
Cleared Mar 23, 1993
VITEK RAPID CALL-GRAM NEGATIV IDENT CARD
K925915
Biomerieux Vitek, Inc.
Microbiology · 120d
Cleared Oct 28, 1991
SCEPTOR IDENTIFICATION SYSTEM
K912897
Bd Becton Dickinson Vacutainer Systems Preanalytic
Microbiology · 119d
Cleared Jun 24, 1991
VITEK GRAM NEGATIVE IDENTIFICATION CARD, MODIFIED
K911429
Vitek Systems, Inc.
Microbiology · 90d
Cleared Jun 09, 1989
SENSITITRE AUTO ID PLATE AP80
K890057
Radiometer America, Inc.
Microbiology · 154d
Cleared Sep 11, 1986
GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL
K862642
American Micro Scan
Microbiology · 62d
Cleared Jul 15, 1985
PASCO GRAM NEGATIVE IDENTIFICATION SYSTEM
K851528
Pasco Laboratories, Inc.
Microbiology · 88d

About Product Code LQM - Regulatory Context