510(k) K940390

IMPACT by Matrix Technologies Corp. — Product Code JQW

K940390 is an FDA 510(k) premarket notification submitted by Matrix Technologies Corp. for the device "IMPACT". The FDA issued a decision of Substantially Equivalent on May 3, 1994. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Matrix Technologies Corp. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1994
Date Received
January 26, 1994
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