FLU OIA A/B TEST KIT
FDA 510(k) clearance K023556 · decided 2003-03-27
Clearance details
- K-number
- K023556
- Device name
- FLU OIA A/B TEST KIT
- Applicant
- Thermo Biostar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-23
- Decision date
- 2003-03-27
- Days to decision
- 155 days
- Clearance type
- Traditional
- Product code
- PSZ
- Device class
- 2
- Regulation number
- 866.3328
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BioStar OIA FLU AB, Catalog 90007. Packaged 30 devices per tray. BioStar, Louisville, CO 8 recall (Z-0212-2009) | Inverness Medical BioStar Inc. | 2008-11-03 |