BION MUMPS-G ANTIBODY TEST SYSTEM
FDA 510(k) clearance K926066 · decided 1993-06-15
Clearance details
- K-number
- K926066
- Device name
- BION MUMPS-G ANTIBODY TEST SYSTEM
- Applicant
- Bion Ent., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1992-12-01
- Decision date
- 1993-06-15
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- CAR
- Device class
- 2
- Regulation number
- 880.2460
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Park Ridge, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product Usage: Product is a used as recall (Z-1479-2013) | Bion Enterprises Ltd | 2013-06-05 |