LAR — Enzyme Immunoassay, Procainamide Class II
FDA product code LAR covers "Enzyme Immunoassay, Procainamide", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 20 recent 510(k) clearances have been granted under this product code.
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 |