AMYLASE LTS— 510(k) K862640

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K862640 for AMYLASE LTS, Substantially Equivalent on 1986-09-09. Applicant: Electro-Nucleonics Laboratories, Inc..

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code CJA
Advisory panel: Clinical Chemistry
Date received: 1986-07-10
Decision date: 1986-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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