A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER— 510(k) K972265
Substantially EquivalentTosoh Medics, Inc.
FDA 510(k) clearance K972265 for A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER, Substantially Equivalent on 1997-09-25. Applicant: Tosoh Medics, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Medics, 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
- Foster City, CA, US
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