510(k) K942241

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

K942241 is an FDA 510(k) premarket notification submitted by Dupont Medical Products for the device "DUPONT APC BLOOD COLLECTION CONTAINER WITH THROMBOPLASTIN". The FDA issued a decision of Substantially Equivalent on August 18, 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 18, 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