510(k) K984574
K984574 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "INFINITY GLUCOSE REAGENT". The FDA issued a decision of Substantially Equivalent on Feb 11, 1999. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Sigma Diagnostics, Inc. has 163 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 11, 1999
- Date Received
- Dec 23, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Hexokinase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
- 510(k)