510(k) K872695
K872695 is an FDA 510(k) premarket notification submitted by Sita, Inc. for the device "PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN". The FDA issued a decision of Substantially Equivalent on September 18, 1987. The device falls under product code GQT (Antisera, Cf, Parainfluenza Virus 1-4), a Class I device regulated under 21 CFR 866.3400. Sita, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 18, 1987
- Date Received
- July 7, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antisera, Cf, Parainfluenza Virus 1-4
- Device Class
- Class I
- Regulation Number
- 866.3400
- Review Panel
- MI
- Submission Type