510(k) K871567
K871567 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "PHENYTOIN FPIA CONTROLS". The FDA issued a decision of Substantially Equivalent on Jul 1, 1987. The device falls under product code LAS (Drug Specific Control Materials), a Class I device regulated under 21 CFR 862.3280. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 1, 1987
- Date Received
- Apr 22, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Drug Specific Control Materials
- Device Class
- Class I
- Regulation Number
- 862.3280
- Review Panel
- TX
- Submission Type
- 510(k) Exempt