AUTOREADER CALIBRATION TEST PLATE— 510(k) K900579

Name: FDA 510(k) clearance K900579
Creator: U.S. Food and Drug Administration
Published: 1990-02-27

Substantially Equivalent

Bio-Tek Instruments, Inc.

FDA 510(k) clearance K900579 for AUTOREADER CALIBRATION TEST PLATE, Substantially Equivalent on 1990-02-27. 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: 1990-02-07
Decision date: 1990-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winooski, VT, US

Download summary PDF View on FDA.gov ↗

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