ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB)— 510(k) K902455
Substantially EquivalentAnalytical Control Systems, Inc.
FDA 510(k) clearance K902455 for ACS NORMAL GLYCOHEMOGLOBIN CONTROL (A1C HGB), Substantially Equivalent on 1990-07-24. Applicant: Analytical Control Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Analytical Control Systems, 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
- Fishers, IN, US
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