510(k) K863423

CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 by Plastic Injectors, Inc. — Product Code JTC

K863423 is an FDA 510(k) premarket notification submitted by Plastic Injectors, Inc. for the device "CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100". The FDA issued a decision of Substantially Equivalent on September 16, 1986. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Plastic Injectors, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1986
Date Received
September 4, 1986
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