SLIDEX ROTA-KIT 2
FDA 510(k) clearance K895805 · decided 1991-02-26
Clearance details
- K-number
- K895805
- Device name
- SLIDEX ROTA-KIT 2
- Applicant
- Vitek Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-09-28
- Decision date
- 1991-02-26
- Days to decision
- 516 days
- Clearance type
- Traditional
- Product code
- LIQ
- Device class
- 1
- Regulation number
- 866.3405
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Hazelwood, MI, 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 |
|---|---|---|
| SAS ROTA TEST (K990842) | Sa Scientific, Inc. | 1999-08-09 |
| VIDAS ROTAVIRUS (RTV) ASSAY (K972895) | Biomerieux Vitek, Inc. | 1997-10-03 |
| IMMUNOCARD STAT! ROTAVIRUS (K971585) | Meridian Diagnostics, Inc. | 1997-08-20 |
| ROTAVIRUS EIA (K964424) | Trinity Biotech, Inc. | 1997-08-08 |
| VIDAS ROTAVIRUS ASSAY (K965092) | Biomerieux Vitek, Inc. | 1997-05-05 |
| ROTA-DAN RAPID ROTAVIRUS EIA KIT (K951208) | Eldan Technologies, Ltd. | 1996-02-14 |
| DIARLEX ROTA-ADENO (K942286) | Orion Diagnostica, Inc. | 1994-12-14 |
| IMMUNOCARD ROTAVIRUS (K933587) | Meridian Diagnostics, Inc. | 1994-02-03 |
| IDEIA(TM) ROTAVIRUS (K932384) | Dako Diagnostics , Ltd. | 1993-12-27 |
| KALLESTAD ROTAVIRUS MICROPLATE (K915137) | Bio-Rad Laboratories, Inc. | 1992-03-04 |
| DAKO ELISA ROTAVIRUS KIT- 96 TESTS K440 (K912666) | Dako Corp. | 1992-02-14 |
| ROTACUBE (K884017) | Difco Laboratories, Inc. | 1989-01-24 |
Recalls involving this device
No recalls on record reference this clearance.