510(k) K023032
K023032 is an FDA 510(k) premarket notification submitted by Bioresource Technology, Inc. for the device "LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL". The FDA issued a decision of Substantially Equivalent on October 8, 2002. The device falls under product code GFS (Standards And Controls, Hemoglobin, Normal And Abnormal), a Class II device regulated under 21 CFR 864.8625. Bioresource Technology, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 2002
- Date Received
- September 11, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Standards And Controls, Hemoglobin, Normal And Abnormal
- Device Class
- Class II
- Regulation Number
- 864.8625
- Review Panel
- HE
- Submission Type