TOXOGEN
FDA 510(k) clearance K913467 · decided 1993-01-11
Clearance details
- K-number
- K913467
- Device name
- TOXOGEN
- Applicant
- Biokit USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-08-05
- Decision date
- 1993-01-11
- Days to decision
- 525 days
- Clearance type
- Traditional
- Product code
- LLA
- Device class
- 2
- Regulation number
- 866.3780
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Barcelona, ES
- 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 |
|---|---|---|
| QUIK-DOT TOXOPLASMOSIS (K890048) | Ampcor, Inc. | 1989-06-09 |
| TOXOSCAN CARD TEST KIT (K850768) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-05-20 |
| TOXO-SCREEN DA TEST (K831930) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1983-09-26 |
Recalls involving this device
No recalls on record reference this clearance.