KAPPA & LAMBDA BENCE JONES CONTROLS
FDA 510(k) clearance K812327 · decided 1981-09-01
Clearance details
- K-number
- K812327
- Device name
- KAPPA & LAMBDA BENCE JONES CONTROLS
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-08-18
- Decision date
- 1981-09-01
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- CZQ
- Device class
- 2
- Regulation number
- 866.5150
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| ANTISERA TO HUMAN FREE LAMBDA LIGHT CH. (K802284) | Kallestad Laboratories, Inc. | 1980-10-23 |
Recalls involving this device
No recalls on record reference this clearance.