ELX800UV— 510(k) K953572

Substantially Equivalent

Bio-Tek Instruments, Inc.

FDA 510(k) clearance K953572 for ELX800UV, Substantially Equivalent on 1995-10-19. Applicant: Bio-Tek Instruments, Inc.. Device class: 1.

Clearance details

Applicant: Bio-Tek Instruments, Inc.
Product code: Code JJQ
Device class: Class 1
Regulation: 21 CFR 862.2300
Advisory panel: Clinical Chemistry
Date received: 1995-07-31
Decision date: 1995-10-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winooski, VT, US

Download summary PDF View on FDA.gov ↗

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