MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL
FDA 510(k) clearance K881259 · decided 1988-10-12
Clearance details
- K-number
- K881259
- Device name
- MAK-6 MONOCLONAL ANTI-CYTOKERATIN COCKTAIL
- Applicant
- Triton Biosciences, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-23
- Decision date
- 1988-10-12
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- LYE
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Alameda, CA, 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 |
|---|---|---|
| ANTI-CYTOKERATIN MONOCLONAL ANTIBODY (K864893) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-07-07 |
Recalls involving this device
No recalls on record reference this clearance.