510(k) K942240

DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN by Dupont Medical Products — Product Code JKA

K942240 is an FDA 510(k) premarket notification submitted by Dupont Medical Products for the device "DUPONT APC BLOOD COLLECTION CONTAINER WITH LITHIUM HEPARIN". The FDA issued a decision of Substantially Equivalent on August 17, 1994. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Dupont Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1994
Date Received
May 9, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type