ACCULYTE CHEMILUMINESCENCE ANALYZER— 510(k) K921536

Name: FDA 510(k) clearance K921536
Creator: U.S. Food and Drug Administration
Published: 1993-10-12

Substantially Equivalent

Laboratory Technologies, Inc.

FDA 510(k) clearance K921536 for ACCULYTE CHEMILUMINESCENCE ANALYZER, Substantially Equivalent on 1993-10-12. Applicant: Laboratory Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Laboratory Technologies, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1992-03-11
Decision date: 1993-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roselle, IL, US

Download summary PDF View on FDA.gov ↗

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