RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN
FDA 510(k) clearance K772078 · decided 1978-02-03
Clearance details
- K-number
- K772078
- Device name
- RADIAL IMMUNODIFFUSION KIT-HAPTOGLOBIN
- Applicant
- Gelman Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-11-03
- Decision date
- 1978-02-03
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- DAB
- Device class
- 2
- Regulation number
- 866.5460
- 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 |
|---|---|---|
| HAPTOGLOBIN IMMUNOLOGICAL TEST KIT (K913670) | The Binding Site, Ltd. | 1991-12-09 |
| FIAX HAPTOGLOBIN TEST KIT (K843570) | Intl. Diagnostic Technology | 1984-10-05 |
Recalls involving this device
No recalls on record reference this clearance.