ANTISERA TO HUMAN FRAGMENT
FDA 510(k) clearance K790711 · decided 1979-09-04
Clearance details
- K-number
- K790711
- Device name
- ANTISERA TO HUMAN FRAGMENT
- Applicant
- Kent Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-04-12
- Decision date
- 1979-09-04
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- DFK
- Device class
- 1
- Regulation number
- 866.5520
- 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 FAB FRAGMENT (K771243) | Kent Laboratories, Inc. | 1977-08-03 |
| FLOR. CONJUG. HUMAN FAB FRAGMENT (K770670) | Kent Laboratories, Inc. | 1977-04-28 |
Recalls involving this device
No recalls on record reference this clearance.