METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM— 510(k) K863840
Substantially EquivalentE.I. Dupont DE Nemours & Co., Inc.
FDA 510(k) clearance K863840 for METH. & CALI. FOR THE DIMENSION CLINI/CHEM. SYSTEM, Substantially Equivalent on 1986-11-05. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 1.
Clearance details
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
- Product code
- Code JJE
- Device class
- Class 1
- Regulation
- 21 CFR 862.2160
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wilmington, DE, US
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More clearances from E.I. Dupont DE Nemours & Co., Inc.
view allAdverse events under product code JJE
product code JJE- Death
- 6
- Injury
- 441
- Malfunction
- 25,011
- Other
- 1
- Total
- 25,459
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.