LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4— 510(k) K970778
Substantially EquivalentMore Diagnostics
FDA 510(k) clearance K970778 for LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4, Substantially Equivalent on 1997-04-17. Applicant: More Diagnostics. Device class: 1.
Clearance details
- Applicant
- More Diagnostics
- 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
- Los Osos, CA, US
Recent devices under product code JJX
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- K982845 — CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3
- K980331 — IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S
- K972976 — CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVEL
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.