RSV OIA
FDA 510(k) clearance K021172 · decided 2002-09-13
Clearance details
- K-number
- K021172
- Device name
- RSV OIA
- Applicant
- Thermo Biostar, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-12
- Decision date
- 2002-09-13
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- GOG
- Device class
- 1
- Regulation number
- 866.3405
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Boulder, 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 |
|---|---|---|
| TRU RSV (K071101) | Meridian Bioscience, Inc. | 2007-10-18 |
| POLIO TYPE I CF ANTIGEN, & TYPE II, III (K853278) | Hillcrest Biologicals | 1985-11-07 |
Recalls involving this device
No recalls on record reference this clearance.