POLIO TYPE I CF ANTIGEN, & TYPE II, III
FDA 510(k) clearance K853278 · decided 1985-11-07
Clearance details
- K-number
- K853278
- Device name
- POLIO TYPE I CF ANTIGEN, & TYPE II, III
- Applicant
- Hillcrest Biologicals
- Decision
- Substantially Equivalent
- Date received
- 1985-08-05
- Decision date
- 1985-11-07
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- GOG
- Device class
- 1
- Regulation number
- 866.3405
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cypress, CA, 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 |
| RSV OIA (K021172) | Thermo Biostar, Inc. | 2002-09-13 |
Recalls involving this device
No recalls on record reference this clearance.