BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT— 510(k) K013062
Substantially EquivalentBiocheck, Inc.
FDA 510(k) clearance K013062 for BIOCHECK HUMAN CARDIAC TROPONIN-I IMMUNOASSAY TEST KIT, Substantially Equivalent on 2002-01-08. Applicant: Biocheck, Inc.. Device class: 2.
Clearance details
- Applicant
- Biocheck, 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
- Northridge, CA, US
Recent devices under product code MMI
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view all- K041619 — BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116
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- K022660 — BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117
- K003851 — BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119
- K002294 — BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.