BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3— 510(k) K851079
Substantially EquivalentBeckman Instruments, Inc.
FDA 510(k) clearance K851079 for BECKMAN TRIGLYCERIDES CONTROL LEVELS 1/2 &3, Substantially Equivalent on 1985-04-10. Applicant: Beckman Instruments, Inc.. Device class: 1.
Clearance details
- Applicant
- Beckman Instruments, Inc.
- Product code
- Code JJX
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fullerton, CA, US
Recent devices under product code JJX
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- K982250 — ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K981403 — IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT
- K981354 — ACCESS AFP REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER MODEL NUMBER 33211
- K980173 — ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.