NEUROCHEMICAL ANALYZER— 510(k) K864729

Substantially Equivalent

Esa, Inc.

FDA 510(k) clearance K864729 for NEUROCHEMICAL ANALYZER, Substantially Equivalent on 1987-04-13. Applicant: Esa, Inc.. Device class: 1.

Clearance details

Applicant: Esa, Inc.
Product code: Code LEQ
Device class: Class 1
Regulation: 21 CFR 862.2260
Advisory panel: Clinical Chemistry
Date received: 1986-12-04
Decision date: 1987-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

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