Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
FDA 510(k) clearance K183223 · decided 2018-12-19
Clearance details
- K-number
- K183223
- Device name
- Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- Applicant
- Diasorin Molecular, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-11-20
- Decision date
- 2018-12-19
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- OZZ
- Device class
- 2
- Regulation number
- 866.3980
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, 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 |
|---|---|---|
| cobas liat Bordetella panel nucleic acid test (K243753) | Roche Molecular Systems, Inc. | 2025-11-20 |
| Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack (K173498) | Diasorin Molecular, LLC | 2018-08-13 |
| Solana Bordetella Complete Assay (K181029) | Quidel Corporation | 2018-07-15 |
| ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit (K163626) | Luminex Corporation | 2017-05-02 |
| Great Basin Bordetella Direct Test (K170284) | Great Basin Scientific, Inc. | 2017-03-31 |
| illumigene Pertussis DNA Amplification Assay (K152285) | Meridian Bioscience, Inc. | 2015-11-10 |
| AmpliVue Bordetella Assay (K143206) | Quidel Corporation | 2014-12-10 |
| ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA (K133673) | Meridian Bioscience, Inc. | 2014-03-25 |
Recalls involving this device
No recalls on record reference this clearance.