PREMIER EHEC
FDA 510(k) clearance K950167 · decided 1995-04-14
Clearance details
- K-number
- K950167
- Device name
- PREMIER EHEC
- Applicant
- Meridian Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-01-17
- Decision date
- 1995-04-14
- Days to decision
- 87 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO BIOSTAR OIA SHIGATOX (K071799) | Iverness Medical Professional Diagnostics | 2007-10-02 |
| DUOPATH VEROTOXINS GLISA TEST (K031367) | Emd Chemicals, Inc. | 2004-01-23 |
| DRYSPOT E.COLI 0157 KIT (K993401) | Oxoid , Ltd. | 2000-02-28 |
| VTEC-RPLA SEIKEN (K981734) | Denka Seiken'S | 1998-09-22 |
| WELLCOLEX E-COLI OI57 ZC60 (K962028) | Murex Diagnostics, Inc. | 1996-11-01 |
| PREMIER EHEC (K953362) | Meridian Diagnostics, Inc. | 1995-11-14 |
| RIM E.COLI 0157:H7 LATEX TEST (K933457) | Remel Co. | 1994-04-20 |
| E. COLI 0157 LATEX TEST (K903714) | Pro-Lab, Inc. | 1991-01-24 |
| ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (K884026) | Oxoid U.S.A., Inc. | 1989-02-03 |
| PHADEBACT ETEC-LT TEST (K874288) | Pharmacia, Inc. | 1988-09-02 |
| DIAGNOSTIC REAGENT VET-RPLA (K855234) | Oxoid U.S.A., Inc. | 1986-11-04 |
Recalls involving this device
No recalls on record reference this clearance.