510(k) K023780
K023780 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "DRI PRIMIDONE CALIBRATORS". The FDA issued a decision of Substantially Equivalent on February 10, 2003. The device falls under product code DLJ (Calibrators, Drug Specific), a Class II device regulated under 21 CFR 862.3200. Microgenics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 2003
- Date Received
- November 12, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrators, Drug Specific
- Device Class
- Class II
- Regulation Number
- 862.3200
- Review Panel
- TX
- Submission Type