510(k) K871976
K871976 is an FDA 510(k) premarket notification submitted by Simmler, Inc. for the device "MULTICHEM GLUCOSE HEXOKINASE REAGENT #S0919". The FDA issued a decision of Substantially Equivalent on Jun 5, 1987. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Simmler, Inc. has 22 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 5, 1987
- Date Received
- May 22, 1987
- 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)