EPISENSOR PLUS
FDA 510(k) clearance K920740 · decided 1994-03-07
Clearance details
- K-number
- K920740
- Device name
- EPISENSOR PLUS
- Applicant
- Industrias Palex C/O Dma Med-Chem Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-02-19
- Decision date
- 1994-03-07
- Days to decision
- 747 days
- Clearance type
- Traditional
- Product code
- CAR
- Device class
- 2
- Regulation number
- 880.2460
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Spain, ES
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| BION MUMPS-G ANTIBODY TEST SYSTEM (K926066) | Bion Ent., Ltd. | 1993-06-15 |
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Recalls involving this device
No recalls on record reference this clearance.