510(k) K905689
K905689 is an FDA 510(k) premarket notification submitted by Microgenics Corp. for the device "CEDIA PHENYTOIN ASSAY". The FDA issued a decision of Substantially Equivalent on January 17, 1991. The device falls under product code DIP (Enzyme Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Microgenics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1991
- Date Received
- December 19, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Immunoassay, Diphenylhydantoin
- Device Class
- Class II
- Regulation Number
- 862.3350
- Review Panel
- TX
- Submission Type