IDI-MRSA
FDA 510(k) clearance K033415 · decided 2004-03-18
Clearance details
- K-number
- K033415
- Device name
- IDI-MRSA
- Applicant
- Infectio Diagnostic (I.D.I.), Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-27
- Decision date
- 2004-03-18
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- NQX
- Device class
- 2
- Regulation number
- 866.1640
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Sainte-Foy, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SmartCycler Diagnostic Software for use with Cepheid brand SmartCycler Real Time PCR Therm recall (Z-1378-05) | Cepheid | 2005-08-17 |