ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK— 510(k) K935550

Substantially Equivalent

Roche Diagnostic Systems, Inc.

FDA 510(k) clearance K935550 for ABUSCREEN ONLINE NEGATIVE CAL/CONTROL CAL PACK AND MIL CALIBRATION PACK, Substantially Equivalent on 1994-01-03. Applicant: Roche Diagnostic Systems, Inc..

Clearance details

Applicant: Roche Diagnostic Systems, Inc.
Product code: Code DKB
Advisory panel: Clinical Toxicology
Date received: 1993-11-17
Decision date: 1994-01-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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