ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
FDA 510(k) clearance K802284 · decided 1980-10-23
Clearance details
- K-number
- K802284
- Device name
- ANTISERA TO HUMAN FREE LAMBDA LIGHT CH.
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-09-19
- Decision date
- 1980-10-23
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- CZQ
- Device class
- 2
- Regulation number
- 866.5150
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Walker, MI, 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 |
|---|---|---|
| KAPPA & LAMBDA BENCE JONES CONTROLS (K812327) | Kallestad Laboratories, Inc. | 1981-09-01 |
Recalls involving this device
No recalls on record reference this clearance.