HDL-C/LDL-C CALIBRATOR, MODEL 1913-003— 510(k) K993098
Substantially EquivalentData Medical Associates, Inc.
FDA 510(k) clearance K993098 for HDL-C/LDL-C CALIBRATOR, MODEL 1913-003, Substantially Equivalent on 1999-10-08. Applicant: Data Medical Associates, Inc.. Device class: 2.
Clearance details
- Applicant
- Data Medical Associates, Inc.
- Product code
- Code JIX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1150
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arlington, TX, US
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