510(k) K905227
K905227 is an FDA 510(k) premarket notification submitted by Enzyme Technology, Inc. for the device "GLUCOSE (HK) REAGENT, UNIVERSAL". The FDA issued a decision of Substantially Equivalent on March 11, 1991. The device falls under product code CFR (Hexokinase, Glucose), a Class II device regulated under 21 CFR 862.1345. Enzyme Technology, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 11, 1991
- Date Received
- November 20, 1990
- 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