LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
FDA 510(k) clearance K023032 · decided 2002-10-08
Clearance details
- K-number
- K023032
- Device name
- LIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMAL
- Applicant
- Bioresource Technology, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-09-11
- Decision date
- 2002-10-08
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- GFS
- Device class
- 2
- Regulation number
- 864.8625
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Fort Lauderdale, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.