K994030

Substantially Equivalent

ONTRAK TESTCUP 5, CAT. 07 6481 7

Applicant: Roche Diagnostics Corp.
Product code: LCM
Advisory panel: Unknown
Date received: 1999-11-26
Decision date: 2000-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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