STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY— 510(k) K965213

Substantially Equivalent

Dade Intl., Inc.

FDA 510(k) clearance K965213 for STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY, Substantially Equivalent on 1997-02-10. Applicant: Dade Intl., Inc..

Clearance details

Applicant: Dade Intl., Inc.
Product code: Code DDR
Advisory panel: Immunology
Date received: 1996-12-30
Decision date: 1997-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.