OPUS PROCAINAMIDE TEST SYSTEM
FDA 510(k) clearance K934762 · decided 1994-07-20
Clearance details
- K-number
- K934762
- Device name
- OPUS PROCAINAMIDE TEST SYSTEM
- Applicant
- Pb Diagnostic Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-04
- Decision date
- 1994-07-20
- Days to decision
- 289 days
- Clearance type
- Traditional
- Product code
- LAR
- Device class
- 2
- Regulation number
- 862.3320
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Westwood, MA, 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 |
| CEDIA PROCAINAMIDE ASSAY (K962099) | Boehringer Mannheim Corp. | 1996-08-27 |
| 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 |
| 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.