DIRECT LDL CHOLESTEROL, MODEL L530-60H— 510(k) K051121
Substantially EquivalentTeco Diagnostics
FDA 510(k) clearance K051121 for DIRECT LDL CHOLESTEROL, MODEL L530-60H, Substantially Equivalent on 2005-08-08. Applicant: Teco Diagnostics. Device class: 1.
Clearance details
- Applicant
- Teco Diagnostics
- Product code
- Code MRR
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Anaheim, CA, US
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More clearances from Teco Diagnostics
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