GMP · Class II · 21 CFR 866.3820

FDA Product Code GMP: Antisera, Control For Nontreponemal Tests

Leading manufacturers include Beckman Instruments, Inc., Texas Immunology, Inc. and Remel, L.P..

9
Total
9
Cleared
90d
Avg days
1981
Since

FDA 510(k) Cleared Antisera, Control For Nontreponemal Tests Devices (Product Code GMP)

9 devices
1–9 of 9
Cleared Jul 06, 1998
ADI SYPHILIS RPR LIQUID CONTROLS
K980638
Ampcor Diagnostics, Inc.
Microbiology · 137d
Cleared Aug 08, 1996
QUALITROL SYPHSERO CONTROL SET
K961998
Consolidated Technologies, Inc.
Microbiology · 78d
Cleared Jul 30, 1996
RPR LIQUID CONTROLS
K955143
Remel, L.P.
Microbiology · 260d
Cleared Feb 04, 1988
V-TREND RPRL CARD TEST
K875180
Texas Immunology, Inc.
Microbiology · 49d
Cleared Sep 23, 1981
BECKMAN R.PR CONTROL SERUM SET
K812425
Beckman Instruments, Inc.
Hematology · 30d

About Product Code GMP - Regulatory Context