LAR · Class II · 21 CFR 862.3320

FDA Product Code LAR: Enzyme Immunoassay, Procainamide

Leading manufacturers include Syva Co., Abbott Laboratories and Roche Diagnostic Systems, Inc..

25
Total
25
Cleared
70d
Avg days
1978
Since

FDA 510(k) Cleared Enzyme Immunoassay, Procainamide Devices (Product Code LAR)

25 devices
1–24 of 25
Cleared Aug 23, 2006
ONLINE TDM PROCAINAMIDE
K060773
Roche Diagnostics Corp.
Toxicology · 154d
Cleared Oct 31, 2003
DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110
K032573
Dade Behring, Inc.
Chemistry · 72d
Cleared Oct 29, 1996
CEDIA N-ACETYLPROCAINAMIDE ASSAY
K963306
Boehringer Mannheim Corp.
Toxicology · 68d
Cleared Aug 27, 1996
CEDIA PROCAINAMIDE ASSAY
K962099
Boehringer Mannheim Corp.
Toxicology · 90d
Cleared Apr 02, 1996
ABBOTT AXSM PROCAINAMIDE ASSAY
K955444
Abbott Laboratories
Toxicology · 126d
Cleared Jul 03, 1995
OPUS PROCAINAMIDE
K951434
Behring Diagnostics, Inc.
Toxicology · 97d
Cleared Dec 02, 1994
COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR
K942847
Roche Diagnostic Systems, Inc.
Toxicology · 169d
Cleared Aug 24, 1992
EMIT 2000 PROCAINAMIDE CALIBRATORS
K922914
Syva Co.
Toxicology · 68d
Cleared Sep 29, 1987
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
K873350
Em Diagnostic Systems, Inc.
Toxicology · 40d
Cleared Feb 11, 1986
STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO.
K860141
American Dade
Toxicology · 28d
Cleared Jul 09, 1985
COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
K852320
Roche Diagnostic Systems, Inc.
Toxicology · 39d
Cleared Apr 12, 1985
EMIT QST PROCAINAMIDE ASSAY
K851061
Syva Co.
Toxicology · 28d
Cleared Feb 03, 1984
TDX PROCAINAMIDE
K834464
Abbott Laboratories
Toxicology · 45d
Cleared Dec 27, 1983
PROCAINAMIDE ANALYTICAL TEST PACK
K833384
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 89d
Cleared Sep 12, 1983
EMIT CAD PROCAINAMIDE ASSAY
K832718
Syva Co.
Toxicology · 31d
Cleared Jun 02, 1983
AMES TDA PROCAINAMIDE TEST
K831400
Miles Laboratories, Inc.
Immunology · 34d
Cleared Nov 29, 1982
ADVANCE EMIT CAD PROCAINAMIDE ASSAY
K823128
Syva Co.
Chemistry · 35d
Cleared Jul 10, 1981
EMIT-CAD PROCAINAMIDE ASSAY
K811770
Syva Co.
Toxicology · 18d
Cleared May 01, 1981
EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY
K811034
Syva Co.
Toxicology · 15d
Cleared Mar 21, 1979
EMIT QUINIDINE ASSAY
K790403
Syva Co.
Toxicology · 23d
Cleared Oct 17, 1978
EMIT PROCAINAMIDE ASSAY
K781382
Syva Co.
Toxicology · 67d

About Product Code LAR - Regulatory Context