510(k) K870953
K870953 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "PHENYTOIN FPIA REAGENT SET". The FDA issued a decision of Substantially Equivalent on Mar 31, 1987. The device falls under product code DIP (Enzyme Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 31, 1987
- Date Received
- Mar 10, 1987
- 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
- 510(k)