ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
FDA 510(k) clearance K840867 · decided 1984-05-11
Clearance details
- K-number
- K840867
- Device name
- ALPHA-1-ANTITRYPSIN, FITC, ANTIGEN
- Applicant
- Intl. Diagnostic Technology
- Decision
- Substantially Equivalent
- Date received
- 1984-02-27
- Decision date
- 1984-05-11
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- DEI
- Device class
- 2
- Regulation number
- 866.5130
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Intl. Diagnostic Technology
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 NEPHEL. ASSAY (K772250) | Kallestad Laboratories, Inc. | 1977-12-22 |
Recalls involving this device
No recalls on record reference this clearance.