BEHRING POLAROID OPUS THEOPHYLLINE— 510(k) K885044

Name: FDA 510(k) clearance K885044
Creator: U.S. Food and Drug Administration
Published: 1988-12-29

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K885044 for BEHRING POLAROID OPUS THEOPHYLLINE, Substantially Equivalent on 1988-12-29. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1988-12-05
Decision date: 1988-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

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