SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS— 510(k) K970314
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K970314 for SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS, Substantially Equivalent on 1997-04-21. Applicant: Beckman Instruments, Inc.. Device class: 1.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- 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
- Brea, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.