ONTRAK TESTCUP-ER— 510(k) K983388

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K983388 for ONTRAK TESTCUP-ER, Substantially Equivalent on 1998-11-18. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DIO
Advisory panel: Clinical Toxicology
Date received: 1998-09-25
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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