510(k) K862905
K862905 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "ALP (OPT) REAGENT". The FDA issued a decision of Substantially Equivalent on Aug 29, 1986. The device falls under product code CJE (Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 29, 1986
- Date Received
- Jul 31, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type
- 510(k)