LAR — Enzyme Immunoassay, Procainamide Class II
FDA Device Classification
Classification Details
- Product Code
- LAR
- Device Class
- Class II
- Regulation Number
- 862.3320
- Submission Type
- Review Panel
- TX
- Medical Specialty
- Clinical Toxicology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K060773 | roche diagnostics | ONLINE TDM PROCAINAMIDE | August 23, 2006 |
| K032573 | dade behring | DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 | October 31, 2003 |
| K010812 | syva co., dade behring | EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 | April 13, 2001 |
| K971716 | bayer | PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | June 27, 1997 |
| K963306 | boehringer mannheim | CEDIA N-ACETYLPROCAINAMIDE ASSAY | October 29, 1996 |
| K962099 | boehringer mannheim | CEDIA PROCAINAMIDE ASSAY | August 27, 1996 |
| K962463 | diagnostic reagents | PROCAINAMIDE ENZYME IMMUNOASSAY | August 14, 1996 |
| K955444 | abbott laboratories | ABBOTT AXSM PROCAINAMIDE ASSAY | April 2, 1996 |
| K951434 | behring diagnostics | OPUS PROCAINAMIDE | July 3, 1995 |
| K942847 | roche diagnostic systems | COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR | December 2, 1994 |
| K934762 | pb diagnostic systems | OPUS PROCAINAMIDE TEST SYSTEM | July 20, 1994 |
| K922914 | syva | EMIT 2000 PROCAINAMIDE CALIBRATORS | August 24, 1992 |
| K873350 | em diagnostic systems | EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 | September 29, 1987 |
| K860141 | american dade | STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNO. | February 11, 1986 |
| K852320 | roche diagnostic systems | COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR | July 9, 1985 |
| K851061 | syva | EMIT QST PROCAINAMIDE ASSAY | April 12, 1985 |
| K834464 | abbott laboratories | TDX PROCAINAMIDE | February 3, 1984 |
| K833384 | e.i. dupont de nemours and co | PROCAINAMIDE ANALYTICAL TEST PACK | December 27, 1983 |
| K832718 | syva | EMIT CAD PROCAINAMIDE ASSAY | September 12, 1983 |
| K831400 | miles laboratories | AMES TDA PROCAINAMIDE TEST | June 2, 1983 |