CEDIA PROCAINAMIDE ASSAY
FDA 510(k) clearance K962099 · decided 1996-08-27
Clearance details
- K-number
- K962099
- Device name
- CEDIA PROCAINAMIDE ASSAY
- Applicant
- Boehringer Mannheim Corp.
- Decision
- Substantially Equivalent
- Date received
- 1996-05-29
- Decision date
- 1996-08-27
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- LAR
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Concord, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ONLINE TDM PROCAINAMIDE (K060773) | Roche Diagnostics Corp. | 2006-08-23 |
| DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 (K032573) | Dade Behring, Inc. | 2003-10-31 |
| EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229 (K010812) | Syva Co., Dade Behring, Inc. | 2001-04-13 |
| PROCAINAMIDE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K971716) | Bayer Corp. | 1997-06-27 |
| CEDIA N-ACETYLPROCAINAMIDE ASSAY (K963306) | Boehringer Mannheim Corp. | 1996-10-29 |
| PROCAINAMIDE ENZYME IMMUNOASSAY (K962463) | Diagnostic Reagents, Inc. | 1996-08-14 |
| ABBOTT AXSM PROCAINAMIDE ASSAY (K955444) | Abbott Laboratories | 1996-04-02 |
| OPUS PROCAINAMIDE (K951434) | Behring Diagnostics, Inc. | 1995-07-03 |
| COBAS(R)-FP REAGENT FOR PROCAINAMIDE/CALIBRATOR (K942847) | Roche Diagnostic Systems, Inc. | 1994-12-02 |
| OPUS PROCAINAMIDE TEST SYSTEM (K934762) | Pb Diagnostic Systems, Inc. | 1994-07-20 |
| EMIT 2000 PROCAINAMIDE CALIBRATORS (K922914) | Syva Co. | 1992-08-24 |
| EASY-TEST EMIT PROCAINAMIDE (PROC) #16648 (K873350) | Em Diagnostic Systems, Inc. | 1987-09-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ENZYMUN TEST{R} CEA (P860058/S001) | Boehringer Mannheim Corp. | 1993-07-29 |
| ENZYMUN-TEST{R} AFP (P860044/S003) | Boehringer Mannheim Corp. | 1991-09-03 |
| ENZYMUN-TEST{R} AFP (P860044/S002) | Boehringer Mannheim Corp. | 1991-07-19 |
| ENZYMUN-TEST{R} AFP (P860044/S001) | Boehringer Mannheim Corp. | 1990-08-03 |
| MICUR-MIC SYSTEMS (P820073) | Boehringer Mannheim Corp. | 1983-06-29 |