AIC - CHEK (HBAIC-I)— 510(k) K973365
Substantially EquivalentExpress-Med, Inc.
FDA 510(k) clearance K973365 for AIC - CHEK (HBAIC-I), Substantially Equivalent on 1998-06-15. Applicant: Express-Med, Inc.. Device class: 2.
Clearance details
- Applicant
- Express-Med, 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
- Columbus, OH, US
Recent devices under product code LCP
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