510(k) K850800

DROPSTIRS - PLASTIC DISPOSABLE PIPET by Berwick Medical Products, Inc. — Product Code JQW

K850800 is an FDA 510(k) premarket notification submitted by Berwick Medical Products, Inc. for the device "DROPSTIRS - PLASTIC DISPOSABLE PIPET". The FDA issued a decision of Substantially Equivalent on April 2, 1985. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Berwick Medical Products, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 1985
Date Received
February 27, 1985
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