510(k) K853920

BIO-TEK EL 401 HANDHELD MICROPLATE WASHER by Bio-Tek Instruments, Inc. — Product Code JTC

K853920 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "BIO-TEK EL 401 HANDHELD MICROPLATE WASHER". The FDA issued a decision of Substantially Equivalent on October 22, 1985. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 1985
Date Received
September 23, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Microtiter Diluting/Dispensing
Device Class
Class I
Regulation Number
866.2500
Review Panel
MI
Submission Type