EASY-TEST CREATININE (CREA) ITEM NO. 19009— 510(k) K874088

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K874088 for EASY-TEST CREATININE (CREA) ITEM NO. 19009, Substantially Equivalent on 1987-11-06. Applicant: Em Diagnostic Systems, Inc..

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code CGX
Advisory panel: Clinical Chemistry
Date received: 1987-10-07
Decision date: 1987-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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