SYNELISA PARIETAL CELL ANTIBODIES
FDA 510(k) clearance K930422 · decided 1993-08-03
Clearance details
- K-number
- K930422
- Device name
- SYNELISA PARIETAL CELL ANTIBODIES
- Applicant
- Elias U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-01-26
- Decision date
- 1993-08-03
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- DBJ
- Device class
- 2
- Regulation number
- 866.5110
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Osceola, WI, 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 |
|---|---|---|
| IIF-APCA TEST KIT (K790759) | Medica Corp. | 1979-07-30 |
Recalls involving this device
No recalls on record reference this clearance.