510(k) K790759
K790759 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "IIF-APCA TEST KIT". The FDA issued a decision of Substantially Equivalent on July 30, 1979. The device falls under product code DBJ (Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5110. Medica Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 30, 1979
- Date Received
- April 17, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antiparietal Antibody, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5110
- Review Panel
- IM
- Submission Type