HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)— 510(k) K931773
Substantially EquivalentKing Diagnostics, Inc.
FDA 510(k) clearance K931773 for HDL PRECIPITATING REAGENT (DEXTRAN SULFATE), Substantially Equivalent on 1993-08-16. Applicant: King Diagnostics, Inc.. Device class: 1.
Clearance details
- Applicant
- King Diagnostics, Inc.
- Product code
- Code LBR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
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More clearances from King Diagnostics, Inc.
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