Product code LAR
- Device name
- Enzyme Immunoassay, Procainamide
- Medical specialty
- Clinical Toxicology
- Device class
- 2
- Regulation number
- 862.3320
- Review panel
- TX
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K060773 | ONLINE TDM PROCAINAMIDE | Roche Diagnostics Corp. | 2006-08-23 |
| K032573 | DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 | Dade Behring, Inc. | 2003-10-31 |
| K010812 | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 | Syva Co., Dade Behring, Inc. | 2001-04-13 |
| K971716 | PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | Bayer Corp. | 1997-06-27 |
| K963306 | CEDIA N-ACETYLPROCAINAMIDE ASSAY | Boehringer Mannheim Corp. | 1996-10-29 |
| K962099 | CEDIA PROCAINAMIDE ASSAY | Boehringer Mannheim Corp. | 1996-08-27 |
| K962463 | PROCAINAMIDE ENZYME IMMUNOASSAY | Diagnostic Reagents, Inc. | 1996-08-14 |
| K955444 | ABBOTT AXSM PROCAINAMIDE ASSAY | Abbott Laboratories | 1996-04-02 |
| K951434 | OPUS PROCAINAMIDE | Behring Diagnostics, Inc. | 1995-07-03 |
| K942847 | COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR | Roche Diagnostic Systems, Inc. | 1994-12-02 |
| K934762 | OPUS PROCAINAMIDE TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1994-07-20 |
| K922914 | EMIT 2000 PROCAINAMIDE CALIBRATORS | Syva Co. | 1992-08-24 |
| K873350 | EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 | Em Diagnostic Systems, Inc. | 1987-09-29 |
| K860141 | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. | American Dade | 1986-02-11 |
| K852320 | COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR | Roche Diagnostic Systems, Inc. | 1985-07-09 |
| K851061 | EMIT QST PROCAINAMIDE ASSAY | Syva Co. | 1985-04-12 |
| K834464 | TDX PROCAINAMIDE | Abbott Laboratories | 1984-02-03 |
| K833384 | PROCAINAMIDE ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1983-12-27 |
| K832718 | EMIT CAD PROCAINAMIDE ASSAY | Syva Co. | 1983-09-12 |
| K831400 | AMES TDA PROCAINAMIDE TEST | Miles Laboratories, Inc. | 1983-06-02 |
| K823128 | ADVANCE EMIT CAD PROCAINAMIDE ASSAY | Syva Co. | 1982-11-29 |
| K811770 | EMIT-CAD PROCAINAMIDE ASSAY | Syva Co. | 1981-07-10 |
| K811034 | EMIT-CAD N-ACETYLPROCAINAMIDE ASSAY | Syva Co. | 1981-05-01 |
| K790403 | EMIT QUINIDINE ASSAY | Syva Co. | 1979-03-21 |
| K781382 | EMIT PROCAINAMIDE ASSAY | Syva Co. | 1978-10-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07613336147900 | ONLINE TDM Procainamide | Roche Diagnostics GmbH | 2020-03-05 |
| 00630414220673 | Atellica CH PROC | Siemens Healthcare Diagnostics Inc. | 2018-10-08 |
| 00842768000980 | Syva® Emit® 2000 Procainamide Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768000997 | Syva® Emit® 2000 Procainamide Calibrators | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768005282 | Dimension® Flex® reagent cartridge PROC | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768015403 | Dimension Vista® Flex® reagent cartridge PROC | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768023262 | Emit® 2000 Procainamide Assay | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630999293 | Procainamide | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630915859 | Procainamide | Roche Diagnostics GmbH | 2016-09-20 |
| 00884883005617 | CEDIA N-Acetylprocainamide Assay | Microgenics Corporation | 2016-09-12 |
| 00884883005624 | CEDIA Procainamide Assay | Microgenics Corporation | 2016-09-12 |