ACS FREEZE-DRIED APTT REAGENT— 510(k) K921223
Substantially EquivalentAnalytical Control Systems, Inc.
FDA 510(k) clearance K921223 for ACS FREEZE-DRIED APTT REAGENT, Substantially Equivalent on 1992-08-18. Applicant: Analytical Control Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Analytical Control Systems, Inc.
- Product code
- Code GFO
- Device class
- Class 2
- Regulation
- 21 CFR 864.7925
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Recent devices under product code GFO
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