TRU RSV
FDA 510(k) clearance K071101 · decided 2007-10-18
Clearance details
- K-number
- K071101
- Device name
- TRU RSV
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-04-19
- Decision date
- 2007-10-18
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- GOG
- Device class
- 1
- Regulation number
- 866.3405
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, 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 |
|---|---|---|
| RSV OIA (K021172) | Thermo Biostar, Inc. | 2002-09-13 |
| 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.