PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN
FDA 510(k) clearance K872697 · decided 1987-09-18
Clearance details
- K-number
- K872697
- Device name
- PARAINFLUENZA-I-CF ANTIGEN AND CONTROL ANTIGEN
- Applicant
- Sita, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-07
- Decision date
- 1987-09-18
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- GQT
- Device class
- 1
- Regulation number
- 866.3400
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Allentown, NJ, 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 |
|---|---|---|
| PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN (K872695) | Sita, Inc. | 1987-09-18 |
| PARAINFLUENZA-3-CF ANTIGEN AND CONTROL ANTIGEN (K872696) | Sita, Inc. | 1987-09-18 |
| GOAT ANTI-INFLUENZA ANTISERA (K780008) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
Recalls involving this device
No recalls on record reference this clearance.