VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK— 510(k) K992366
Substantially EquivalentOrtho-Clinical Diagnostics, Inc.
FDA 510(k) clearance K992366 for VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK, Substantially Equivalent on 1999-10-08. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- 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
view allMore clearances from Ortho-Clinical Diagnostics, Inc.
view all- DEN210038 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
- DEN210040 — VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
- K210858 — VITROS Chemistry Products PHBR Slides
- K191316 — VITROS XT Chemistry Products ALB-TP Slides
- K190807 — VITROS XT Chemistry Products TBIL-ALKP Slides
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 K992366
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 K992366.
Data sourced from openFDA. This site is unofficial and independent of the FDA.