Simplexa GBS Direct, Simplexa GBS Positive Control Pack
FDA 510(k) clearance K182467 · decided 2018-11-07
Clearance details
- K-number
- K182467
- Device name
- Simplexa GBS Direct, Simplexa GBS Positive Control Pack
- Applicant
- Diasorin Molecular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-09-10
- Decision date
- 2018-11-07
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- NJR
- Device class
- 1
- Regulation number
- 866.3740
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, US
- Third-party review
- No
- Expedited review
- No
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| ARIES GBS Assay (K162772) | Luminex Corporation | 2016-12-23 |
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| AMPLIVUE GBS ASSAY (K133503) | Quidel Corporation | 2013-12-20 |
| XPERT GBS LB GENEXPERT DX SYSTEMS (GX-I, GX-IV) GENEXPERT DX SYSTEMS (GX-XVI) GENEXPERT INFINITY-48 SYSTEM (900-XXXX) (K121539) | Cepheid | 2012-11-02 |
| ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM (K121044) | Meridian Bioscience, Inc. | 2012-05-01 |
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Recalls involving this device
No recalls on record reference this clearance.