510(k) K813042
K813042 is an FDA 510(k) premarket notification submitted by Harleco for the device "ULTRACHEM GLUC-DH SET, ITEM #65048". The FDA issued a decision of Substantially Equivalent on November 10, 1981. The device falls under product code LFR (Glucose Dehydrogenase, Glucose), a Class II device regulated under 21 CFR 862.1345. Harleco has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 10, 1981
- Date Received
- October 28, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Glucose Dehydrogenase, Glucose
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type