RIA/MAT FPA TEST KIT
FDA 510(k) clearance K884496 · decided 1988-11-16
Clearance details
- K-number
- K884496
- Device name
- RIA/MAT FPA TEST KIT
- Applicant
- Altana, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-10-25
- Decision date
- 1988-11-16
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- DAN
- Device class
- 2
- Regulation number
- 866.5350
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Melville, 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 |
|---|---|---|
| ASSERACHROM FPA KIT (K854384) | American Bioproducts Co. | 1986-02-04 |
| RIA-QUANT FPA TEST KIT (K821151) | Mallinckrodt Critical Care | 1982-07-22 |
Recalls involving this device
No recalls on record reference this clearance.