GEMSTAR IPA THEOPHYLLINE TEST KIT— 510(k) K853372

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K853372 for GEMSTAR IPA THEOPHYLLINE TEST KIT, Substantially Equivalent on 1985-09-04. Applicant: Electro-Nucleonics Laboratories, Inc..

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code KLS
Advisory panel: Clinical Toxicology
Date received: 1985-08-12
Decision date: 1985-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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