ARCHITECT STAT TROPONIN-I IMMUNOASSAY— 510(k) K041192
Substantially EquivalentFisher Diagnostics
FDA 510(k) clearance K041192 for ARCHITECT STAT TROPONIN-I IMMUNOASSAY, Substantially Equivalent on 2004-08-12. Applicant: Fisher Diagnostics. Device class: 2.
Clearance details
- Applicant
- Fisher 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
- Middletown, VA, US
Recent devices under product code MMI
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view all- K170652 — ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibrators, ARCHITECT B.R.A.H.M.S PCT Controls
- K070640 — ARCHITECT STAT TROPONIN-1; MYOGLOBIN
- K052407 — ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
- K052308 — ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM ASSAY CD-ROM
- K042924 — ARCHITECT STAT MYO IMMUNOASSAY
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 K041192
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 K041192.
Data sourced from openFDA. This site is unofficial and independent of the FDA.