Panels › Clinical Toxicology › Product code LAR · Class 2
Enzyme Immunoassay, Procainamide
Regulation 862.3320
0510(k)s in 12 months (25 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LAR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 23, 2006 | K060773 | ONLINE TDM PROCAINAMIDE Roche Diagnostics Corp. | LAR |
| Oct 31, 2003 | K032573 | DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 Dade Behring, Inc. | LAR |
| Apr 13, 2001 | K010812 | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 Syva Co., Dade Behring, Inc. | LAR |
| Jun 27, 1997 | K971716 | PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM Bayer Corp. | LAR |
| Oct 29, 1996 | K963306 | CEDIA N-ACETYLPROCAINAMIDE ASSAY Boehringer Mannheim Corp. | LAR |
| Aug 27, 1996 | K962099 | CEDIA PROCAINAMIDE ASSAY Boehringer Mannheim Corp. | LAR |
| Aug 14, 1996 | K962463 | PROCAINAMIDE ENZYME IMMUNOASSAY Diagnostic Reagents, Inc. | LAR |
| Apr 2, 1996 | K955444 | ABBOTT AXSM PROCAINAMIDE ASSAY Abbott Laboratories | LAR |
| Jul 3, 1995 | K951434 | OPUS PROCAINAMIDE Behring Diagnostics, Inc. | LAR |
| Dec 2, 1994 | K942847 | COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR Roche Diagnostic Systems, Inc. | LAR |
| Jul 20, 1994 | K934762 | OPUS PROCAINAMIDE TEST SYSTEM Pb Diagnostic Systems, Inc. | LAR |
| Aug 24, 1992 | K922914 | EMIT 2000 PROCAINAMIDE CALIBRATORS Syva Co. | LAR |
| Sep 29, 1987 | K873350 | EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 Em Diagnostic Systems, Inc. | LAR |
| Feb 11, 1986 | K860141 | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. American Dade | LAR |
| Jul 9, 1985 | K852320 | COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR Roche Diagnostic Systems, Inc. | LAR |
| Apr 12, 1985 | K851061 | EMIT QST PROCAINAMIDE ASSAY Syva Co. | LAR |
| Feb 3, 1984 | K834464 | TDX PROCAINAMIDE Abbott Laboratories | LAR |
| Dec 27, 1983 | K833384 | PROCAINAMIDE ANALYTICAL TEST PACK E.I. Dupont DE Nemours & Co., Inc. | LAR |
| Sep 12, 1983 | K832718 | EMIT CAD PROCAINAMIDE ASSAY Syva Co. | LAR |
| Jun 2, 1983 | K831400 | AMES TDA PROCAINAMIDE TEST Miles Laboratories, Inc. | LAR |
| Nov 29, 1982 | K823128 | ADVANCE EMIT CAD PROCAINAMIDE ASSAY Syva Co. | LAR |
| Jul 10, 1981 | K811770 | EMIT-CAD PROCAINAMIDE ASSAY Syva Co. | LAR |
| May 1, 1981 | K811034 | EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY Syva Co. | LAR |
| Mar 21, 1979 | K790403 | EMIT QUINIDINE ASSAY Syva Co. | LAR |
| Oct 17, 1978 | K781382 | EMIT PROCAINAMIDE ASSAY Syva Co. | LAR |
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