ROCHE COBAS INTEGRA SERUM BARBITURATES— 510(k) K991440

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K991440 for ROCHE COBAS INTEGRA SERUM BARBITURATES, Substantially Equivalent on 1999-06-22. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DIS
Advisory panel: Clinical Toxicology
Date received: 1999-04-26
Decision date: 1999-06-22
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.