MODIFIED OPUS PHENOBARBITAL TEST SYSTEM— 510(k) K901537

Name: FDA 510(k) clearance K901537
Creator: U.S. Food and Drug Administration
Published: 1990-06-12

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K901537 for MODIFIED OPUS PHENOBARBITAL TEST SYSTEM, Substantially Equivalent on 1990-06-12. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LET
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1990-04-02
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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