Great Basin Staph ID/R Blood Culture Panel
FDA 510(k) clearance K152470 · decided 2016-03-25
Clearance details
- K-number
- K152470
- Device name
- Great Basin Staph ID/R Blood Culture Panel
- Applicant
- Great Basin Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-31
- Decision date
- 2016-03-25
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- PAM
- Device class
- 2
- Regulation number
- 866.3365
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
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