COBAS STANDARD FOR TOTAL PROTEIN
FDA 510(k) clearance K823576 · decided 1983-01-07
Clearance details
- K-number
- K823576
- Device name
- COBAS STANDARD FOR TOTAL PROTEIN
- Applicant
- Hoffmann-La Roche, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-12-06
- Decision date
- 1983-01-07
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- LER
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| THEOPHYLLINE FPIA REAGENT SET AND CALIBRATORS (K942192) | Sigma Diagnostics, Inc. | 1994-07-13 |
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| TURBOX THEOPHYLLINE ASSAY (K882570) | Unipath , Ltd. | 1988-11-10 |
| IMMPULSE COATED TUBE THEOPHYLLINE ASSAY REAGENTS (K864409) | Sclavo, Inc. | 1986-12-22 |
| THEOFAST(TM) TEST PACKAGE (K863475) | 3M Company | 1986-11-05 |
| THEOPHYLLINE KIT FLUORESCENCE POLARIZA- (K842585) | Windsor Laboratories, Inc. | 1984-09-26 |
| IMMPULSE THEOPHYLLINE ASSAY REAGENTS (K840758) | Paragon Diagnostics, Inc. | 1984-04-04 |
| TDX THEOPHYLLINE (K833070) | Abbott Laboratories | 1983-11-14 |
| AMWA TDA THEOPHYLLINE TEST (K831514) | Miles Laboratories, Inc. | 1983-06-30 |
| AMERIFLUOR THEOPHYLLINE FLUORESCENT IMM (K820397) | American Diagnostic Corp. | 1982-03-02 |
| EMIT-AAD THEOPHYLLINE ASSAY (K813240) | Syva Co. | 1981-12-03 |
| AMES TDA THEOPHYLLINE TEST (K812518) | Miles Laboratories, Inc. | 1981-09-23 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CEA-ROCHE TEST KIT (P800063/S004) | Hoffmann-La Roche, Inc. | 1983-10-18 |
| CEA-ROCHE TEST KIT (P800063/S003) | Hoffmann-La Roche, Inc. | 1982-10-21 |
| CEA-ROCHE TEST KIT (P800063/S002) | Hoffmann-La Roche, Inc. | 1982-09-16 |
| CEA-ROCHE TEST KIT (P800063/S001) | Hoffmann-La Roche, Inc. | 1982-03-03 |