PanNAT STEC Test
FDA 510(k) clearance K173330 · decided 2018-06-01
Clearance details
- K-number
- K173330
- Device name
- PanNAT STEC Test
- Applicant
- Micronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-10-23
- Decision date
- 2018-06-01
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- PCI
- Device class
- 2
- Regulation number
- 866.3990
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Great Basin Stool Bacterial Pathogens Panel (K163571) | Great Basin Scientific, Inc. | 2017-07-12 |
| BD MAX(TM) ENTERIC BACTERIAL PANEL;BD MAX(TM) INSTRUMENT (K140111) | Becton, Dickinson and Company | 2014-05-06 |
Recalls involving this device
No recalls on record reference this clearance.