VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303— 510(k) K062838
Substantially EquivalentOrtho-Clinical Diagnostics
FDA 510(k) clearance K062838 for VITROS TROPONIN I ES ASSAY, INCLUDING REAGENT PACK, CALIBRATORS AND RANGE VERIFIERS, MODELS 680 2301, 2302 AND 2303, Substantially Equivalent on 2006-12-19. Applicant: Ortho-Clinical Diagnostics. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics
- Product code
- Code MMI
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code MMI
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view all- K241534 — VITROS Immunodiagnostic Products Syphilis Reagent Pack
- K233581 — VITROS Immunodiagnostic Products Total ß-hCG II Reagent Pack
- K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack
- K231517 — VITROS Immunodiagnostic Products CEA Reagent Pack
- K231525 — VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack
Adverse events under product code MMI
product code MMI- Injury
- 172
- Malfunction
- 3,762
- Total
- 3,934
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 K062838
K-number listed on FDA's recall record- Z-2357-2023 — VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
- Z-2358-2023 — VITROS Immunodiagnostic Products Troponin I ES Calibrators
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K062838.
Data sourced from openFDA. This site is unofficial and independent of the FDA.