510(k) K913858
K913858 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "AMYLASE REAGENT (PROCEDURE 577)". The FDA issued a decision of Substantially Equivalent on Sep 11, 1991. The device falls under product code JFJ (Catalytic Methods, Amylase), a Class II device regulated under 21 CFR 862.1070. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 1991
- Date Received
- Aug 27, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Catalytic Methods, Amylase
- Device Class
- Class II
- Regulation Number
- 862.1070
- Review Panel
- CH
- Submission Type
- 510(k)