ANTISERA, RHODAMINE CONJUGATED FRAGMENT
FDA 510(k) clearance K781951 · decided 1979-02-16
Clearance details
- K-number
- K781951
- Device name
- ANTISERA, RHODAMINE CONJUGATED FRAGMENT
- Applicant
- Kallestad Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-11-21
- Decision date
- 1979-02-16
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DCE
- 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 |
|---|---|---|
| FLUORESCEIN CONJUGATED (K772128) | Kallestad Laboratories, Inc. | 1977-11-22 |
Recalls involving this device
No recalls on record reference this clearance.