KODAK EKTACCHEM 950IRC ANALYZER— 510(k) K946090
Substantially EquivalentClinical Diagnostic Systems, Inc.
FDA 510(k) clearance K946090 for KODAK EKTACCHEM 950IRC ANALYZER, Substantially Equivalent on 1995-01-17. Applicant: Clinical Diagnostic Systems, Inc.. Device class: 1.
Clearance details
- Applicant
- Clinical Diagnostic Systems, 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
- Rochester, NY, US
Recent devices under product code JJE
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- K130915 — XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE REAGENT PACK
- K131554 — RX DAYTONA PLUS CHEMISTRY ANALYZER; RX DAYTONA PLUS ASPARTATE AMINOTRANSFERASE (AST) REAGENT
- K130276 — DIMENSION EXL WITH LM SYSTEM
Adverse 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 →
Recalls naming K946090
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K946090.
Data sourced from openFDA. This site is unofficial and independent of the FDA.