ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS— 510(k) K082699
Substantially EquivalentRoche Diagnostics
FDA 510(k) clearance K082699 for ELECSYS TROPONIN I AND TROPONIN I STAT TEST SYSTEMS, Substantially Equivalent on 2009-08-19. Applicant: Roche Diagnostics. Device class: 2.
Clearance details
- Applicant
- Roche 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
- Indianapolis, IN, US
Recent devices under product code MMI
view allMore clearances from Roche Diagnostics
view allAdverse 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 K082699
K-number listed on FDA's recall record- Z-1595-2021 — Elecsys Troponin I STAT Immunoassay: Catalog# 05094798160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
- Z-1596-2021 — Elecsys Troponin I Immunoassay: Catalog# 05094810160 - Product Usage: intended to aid in the diagnosis of myocardial infarction.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K082699.
Data sourced from openFDA. This site is unofficial and independent of the FDA.