510(k) K790025
K790025 is an FDA 510(k) premarket notification submitted by Diagnostic Technology, Inc. for the device "COUNTER CHECK, H001, H002, H003". The FDA issued a decision of Substantially Equivalent on January 17, 1979. The device falls under product code KSF (Kit, Quality Control For Blood Banking Reagents), a Class II device regulated under 21 CFR 864.9650. Diagnostic Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1979
- Date Received
- January 3, 1979
- 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