TECHNICON DPA-1 IMMUNOGLOBULIN M
FDA 510(k) clearance K883493 · decided 1988-09-22
Clearance details
- K-number
- K883493
- Device name
- TECHNICON DPA-1 IMMUNOGLOBULIN M
- Applicant
- Technicon Instruments Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-16
- Decision date
- 1988-09-22
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- DFL
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Tarrytown, NY, 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 |
|---|---|---|
| FIAGEN FERRITIN (K882822) | Cyberfluor, Inc. | 1988-08-04 |
| RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M (K772079) | Gelman Instrument Co. | 1978-02-03 |
Recalls involving this device
No recalls on record reference this clearance.