PREMIER EHEC
FDA 510(k) clearance K953362 · decided 1995-11-14
Clearance details
- K-number
- K953362
- Device name
- PREMIER EHEC
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-17
- Decision date
- 1995-11-14
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- GNA
- Device class
- 1
- Regulation number
- 866.3255
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PREMIER EHEC and PREMIER EHEC Bulk. recall (Z-1033-2017) | Meridian Bioscience Inc | 2017-01-17 |
| EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100 recall (Z-0203-2012) | Meridian Bioscience Inc | 2011-11-17 |