VARELISA PARIETAL CELL ANTIBODIES
FDA 510(k) clearance K951206 · decided 1995-04-17
Clearance details
- K-number
- K951206
- Device name
- VARELISA PARIETAL CELL ANTIBODIES
- Applicant
- Elias U.S.A., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-17
- Decision date
- 1995-04-17
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- MLE
- 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 |
|---|---|---|
| QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA (K010558) | Inova Diagnostics, Inc. | 2001-04-03 |
| AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA (K991942) | Cogent Diagnotics , Ltd. | 1999-08-24 |
Recalls involving this device
No recalls on record reference this clearance.