MODEL 5500 CEAS— 510(k) K934977

Substantially Equivalent

Esa, Inc.

FDA 510(k) clearance K934977 for MODEL 5500 CEAS, Substantially Equivalent on 1994-01-11. Applicant: Esa, Inc.. Device class: 1.

Clearance details

Applicant: Esa, Inc.
Product code: Code CDF
Device class: Class 1
Regulation: 21 CFR 862.1795
Advisory panel: Clinical Chemistry
Date received: 1993-10-19
Decision date: 1994-01-11
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.