ANTISERUM TO HUMAN HEMOPEXIN
FDA 510(k) clearance K790713 · decided 1979-09-04
Clearance details
- K-number
- K790713
- Device name
- ANTISERUM TO HUMAN HEMOPEXIN
- 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
- CZX
- Device class
- 2
- Regulation number
- 866.5490
- 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 |
|---|---|---|
| HEMOPEXIN NEPHELOMETRIC ASSAY (K801432) | J.T. Baker Chemical Co. | 1980-07-08 |
| HEMOPEXIN NEPHELOMETRIC ASSAYS (K780250) | Kallestad Laboratories, Inc. | 1978-02-28 |
Recalls involving this device
No recalls on record reference this clearance.