EMIT II OPIATES 300/2000 ASSAY— 510(k) K971596

Name: FDA 510(k) clearance K971596
Creator: U.S. Food and Drug Administration
Published: 1997-06-25

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K971596 for EMIT II OPIATES 300/2000 ASSAY, Substantially Equivalent on 1997-06-25. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code DJG
Device class: Class 2
Regulation: 21 CFR 862.3650
Advisory panel: Clinical Toxicology
Date received: 1997-05-01
Decision date: 1997-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Jose, CA, US

Download summary PDF View on FDA.gov ↗

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