510(k) K173498
- Device
- Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack
- Applicant
- DiaSorin Molecular LLC
- 510(k) number
- K173498
- Product code
- OZZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-08-13
- Date received
- 2017-11-13
- Regulation
- 866.3980
- Classification name
- Bordetella Pertussis Dna Assay System
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Sharon Young
- Address
- 11331 Valley View St. Cypress CA US 90630 90630
FDA Registration Numbers#
- 3003030793
- 3010770794
- 3004141078
- 2023365
- 3010749841
- 1528450
- 3007799234
- 1524213
- 1650733
- 3006198300
- 3002773840
- 2243471
- 3006028115
Source Documents#
Other 510(k) Records For Product Code OZZ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K243753 | cobas liat Bordetella panel nucleic acid test | Roche Molecular Systems, Inc. | 2025-11-20 |
| K183223 | Simplexa Bordetella Direct, Simplexa Bordetella Positive Control Pack | Diasorin Molecular, LLC | 2018-12-19 |
| K181029 | Solana Bordetella Complete Assay | Quidel Corporation | 2018-07-15 |
| K163626 | ARIES Bordetella Assay; ARIES Bordetella Assay Protocol File Kit | Luminex Corporation | 2017-05-02 |
| K170284 | Great Basin Bordetella Direct Test | Great Basin Scientific, Inc. | 2017-03-31 |
| K152285 | illumigene Pertussis DNA Amplification Assay | Meridian Bioscience, Inc. | 2015-11-10 |
| K143206 | AmpliVue Bordetella Assay | Quidel Corporation | 2014-12-10 |
| K133673 | ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA | Meridian Bioscience, Inc. | 2014-03-25 |
Legacy Summary#
summary
FDA Review#
Decision Summary