510(k) K811713
K811713 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "AVI-D CONTROL". The FDA issued a decision of Substantially Equivalent on October 23, 1981. The device falls under product code KSF (Kit, Quality Control For Blood Banking Reagents), a Class II device regulated under 21 CFR 864.9650. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 23, 1981
- Date Received
- June 17, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Quality Control For Blood Banking Reagents
- Device Class
- Class II
- Regulation Number
- 864.9650
- Review Panel
- HE
- Submission Type