SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC— 510(k) K991850
Substantially EquivalentBiosafe Laboratories, Inc.
FDA 510(k) clearance K991850 for SAFE AT-HOME TEST KIT FOR MONITORING HEMOGLOBIN ALC, Substantially Equivalent on 1999-11-26. Applicant: Biosafe Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Biosafe Laboratories, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lincolnshire, IL, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.