CEDIA Buprenorphine II Assay +3 more— 510(k) K163101

Name: FDA 510(k) clearance K163101
Creator: U.S. Food and Drug Administration
Published: 2017-04-06

Substantially Equivalent

Microgenics Corporation

FDA 510(k) clearance K163101 for CEDIA Buprenorphine II Assay +3 more, Substantially Equivalent on 2017-04-06. Applicant: Microgenics Corporation. Device class: 2.

Clearance details

Device name as filed: CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set
Applicant: Microgenics Corporation
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 2016-11-07
Decision date: 2017-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fremont, CA, US

Download summary PDF View on FDA.gov ↗

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