KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
FDA 510(k) clearance K102342 · decided 2011-05-05
Clearance details
- K-number
- K102342
- Device name
- KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT
- Applicant
- Microphage, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-08-18
- Decision date
- 2011-05-05
- Days to decision
- 260 days
- Clearance type
- Traditional
- Product code
- OUS
- Device class
- 1
- Regulation number
- 866.2050
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Longmont, CO, 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 |
|---|---|---|
| KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT (K120563) | Microphage, Inc. | 2012-03-30 |
Recalls involving this device
No recalls on record reference this clearance.