DIAZYME APOLIPOPROTEIN A-1 ASSAY— 510(k) K072977
Substantially EquivalentGeneral Atomics
FDA 510(k) clearance K072977 for DIAZYME APOLIPOPROTEIN A-1 ASSAY, Substantially Equivalent on 2008-07-16. Applicant: General Atomics. Device class: 1.
Clearance details
- Applicant
- General Atomics
- Product code
- Code MSJ
- Device class
- Class 1
- Regulation
- 21 CFR 862.1475
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Poway, CA, US
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More clearances from General Atomics
view allData sourced from openFDA. This site is unofficial and independent of the FDA.