ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
FDA 510(k) clearance K772250 · decided 1977-12-22
Clearance details
- K-number
- K772250
- Device name
- ALPHA-1-ANTITRYPSIN NEPHEL. ASSAY
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-12-09
- Decision date
- 1977-12-22
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- DEI
- Device class
- 2
- Regulation number
- 866.5130
- 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 |
|---|---|---|
| ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN (K840867) | Intl. Diagnostic Technology | 1984-05-11 |
Recalls involving this device
No recalls on record reference this clearance.