RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M
FDA 510(k) clearance K772079 · decided 1978-02-03
Clearance details
- K-number
- K772079
- Device name
- RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M
- 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
- DFL
- Device class
- 2
- Regulation number
- 866.5550
- 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 |
|---|---|---|
| TECHNICON DPA-1 IMMUNOGLOBULIN M (K883493) | Technicon Instruments Corp. | 1988-09-22 |
| FIAGEN FERRITIN (K882822) | Cyberfluor, Inc. | 1988-08-04 |
Recalls involving this device
No recalls on record reference this clearance.