GEMENI GPT (ALT) ASSAY— 510(k) K761269

Substantially Equivalent

Electro-Nucleonics Laboratories, Inc.

FDA 510(k) clearance K761269 for GEMENI GPT (ALT) ASSAY, Substantially Equivalent on 1976-12-29. Applicant: Electro-Nucleonics Laboratories, Inc..

Clearance details

Applicant: Electro-Nucleonics Laboratories, Inc.
Product code: Code CKA
Advisory panel: Clinical Chemistry
Date received: 1976-12-16
Decision date: 1976-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.