ENZYMATIC THEOPHYLLINE REAGENT, #500-82— 510(k) K901510

Name: FDA 510(k) clearance K901510
Creator: U.S. Food and Drug Administration
Published: 1990-06-12

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K901510 for ENZYMATIC THEOPHYLLINE REAGENT, #500-82, Substantially Equivalent on 1990-06-12. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 2.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1990-03-30
Decision date: 1990-06-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oxford, CT, US

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