EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93— 510(k) K862308

Name: FDA 510(k) clearance K862308
Creator: U.S. Food and Drug Administration
Published: 1986-07-07

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K862308 for EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93, Substantially Equivalent on 1986-07-07. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1986-06-17
Decision date: 1986-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

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