510(k) K852320
- Device
- COBAS FP REAGEN FOR PROCAINAMIDE & PRO CALIBRATOR
- Applicant
- ROCHE DIAGNOSTIC SYSTEMS, INC.
- 510(k) number
- K852320
- Product code
- LAR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-07-09
- Date received
- 1985-05-31
- Regulation
- 862.3320
- Classification name
- Enzyme Immunoassay, Procainamide
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DONALD KAFADER
- Address
- Div. Of Hoffmann-La Roche, Inc Nutley NJ US 07110 07110
FDA Registration Numbers#
- 9610126
- 3006198300
- 3010939897
- 3003795116
- 3010825766
- 2517506
- 2432235
- 9610529
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LAR #
| 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 |
| K851061 | EMIT QST PROCAINAMIDE ASSAY | Syva Co. | 1985-04-12 |
Legacy Summary#
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FDA Review#
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