RIA-QUANT FPA TEST KIT
FDA 510(k) clearance K821151 · decided 1982-07-22
Clearance details
- K-number
- K821151
- Device name
- RIA-QUANT FPA TEST KIT
- Applicant
- Mallinckrodt Critical Care
- Decision
- Substantially Equivalent
- Date received
- 1982-04-26
- Decision date
- 1982-07-22
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DAN
- Device class
- 2
- Regulation number
- 866.5350
- 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 |
|---|---|---|
| RIA/MAT FPA TEST KIT (K884496) | Altana, Inc. | 1988-11-16 |
| ASSERACHROM FPA KIT (K854384) | American Bioproducts Co. | 1986-02-04 |
Recalls involving this device
No recalls on record reference this clearance.