INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
FDA 510(k) clearance K955567 · decided 1996-01-24
Clearance details
- K-number
- K955567
- Device name
- INNOFLUOR THEOPHYLLINE ASSAY SYSTEM
- Applicant
- Oxis Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-12-06
- Decision date
- 1996-01-24
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- LGS
- Device class
- 2
- Regulation number
- 862.3880
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Portland, OR, 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 |
|---|---|---|
| ARCHITECT I THEOPHYLLINE REAGENTS AND CALIBRATORS (A-F) (K070810) | Biokit, S.A. | 2007-06-08 |
| AXSYM THEOPHYLLINE II (K953016) | Abbott Laboratories | 1995-08-24 |
| CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY (K951169) | Ciba Corning Diagnostics Corp. | 1995-06-20 |
| QMS THEOPHYLLINE CS (K942991) | Seradyn, Inc. | 1994-09-09 |
| TDX/TDXFLX & TDXFLX THEOPHYLLINE MONOCLONAL II (K932127) | Abbott Laboratories | 1993-08-09 |
| ABBOTT TDX/TDXFLX AND TDXFLX THEOPHYLLINE (K922991) | Abbott Laboratories | 1992-08-27 |
| MODIFIED ACCUFLUOR THEOPHYLLINE REAGENT & CALIBRA (K900706) | Innotron of Oregon, Inc. | 1990-04-12 |
| FPR THEOPHYLLINE KIT (K894529) | Colony Laboratories, Inc. | 1989-09-15 |
| COBAS FP REAGENTS FOR THEOPHYLLINE & CALIBRATORS (K871484) | Roche Diagnostic Systems, Inc. | 1987-05-28 |
| MONITORX LASERX THEOPHYLLINE REAGENT SET (K870277) | American Monitor Corp. | 1987-02-18 |
| INNOFLUOR THEOPHYLLINE (K850629) | Innotron Diagnostics | 1985-03-12 |
| COBAS IMMUNOASSAY FOR THEOPHYLLINE & CAL (K843826) | Roche Diagnostic Systems, Inc. | 1985-02-01 |
Recalls involving this device
No recalls on record reference this clearance.