510(k) K120563
- Device
- KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT
- Applicant
- MICROPHAGE, INC.
- 510(k) number
- K120563
- Product code
- OUS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2012-03-30
- Date received
- 2012-02-24
- Regulation
- 866.2050
- Classification name
- Methicillin Resistant Staphylococcus Aureus/methicillin Susceptible Staphylococcus Aureus Blood Culture Test Bt
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- DREW SMITH
- Address
- 2400 Trade Centre Ave. Longmont CO US 80503 80503
Source Documents
Other 510(k) Records For Product Code OUS
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102342 | KEYPATH(TM) MRSA/MSSA BLOOD CULTURE TEST- BT | Microphage, Inc. | 2011-05-05 |
Legacy Summary
summary
FDA Review
Decision Summary