FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
FDA 510(k) clearance K843613 · decided 1984-10-31
Clearance details
- K-number
- K843613
- Device name
- FLUORESCENT TREPONEMEL ANTIBODY-ABSORB
- Applicant
- Immuno-Products Industries
- Decision
- Substantially Equivalent
- Date received
- 1984-09-10
- Decision date
- 1984-10-31
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- GMS
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- So. Bound Brook, NJ, 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 |
|---|---|---|
| IMMUNO-PROD IND FLUORE TREPONE ANTIBODY ABSORPED (K853122) | Immuno-Products Industries | 1985-09-19 |
| FTA-ABS TEST SYSTEM (K781403) | Zeus Scientific, Inc. | 1978-08-21 |
Recalls involving this device
No recalls on record reference this clearance.