ADENOVIRUS CF ANTIGEN AND CONTROL ANTIGEN
FDA 510(k) clearance K872698 · decided 1987-09-18
Clearance details
- K-number
- K872698
- Device name
- ADENOVIRUS 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
- GOA
- Device class
- 1
- Regulation number
- 866.3020
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Allentown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.