510(k) K961896

MICROLAB 4000, MICROLAB 4200 by Hamilton Co. — Product Code JQW

K961896 is an FDA 510(k) premarket notification submitted by Hamilton Co. for the device "MICROLAB 4000, MICROLAB 4200". The FDA issued a decision of Substantially Equivalent on August 16, 1996. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Hamilton Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 1996
Date Received
May 16, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type