DeviceClearance

DADE STRATUS TROPONIN-I CONTROL— 510(k) K951888

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K951888 for DADE STRATUS TROPONIN-I CONTROL, Substantially Equivalent on 1995-07-13. Applicant: Dade Intl., Inc..

Clearance details

Applicant
Dade Intl., Inc.
Product code
Code JJX
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Miami, FL, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code JJX

product code JJX
Other
2
Total
2

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.