510(k) K040879

QUANTEX FERRITIN by Instrumentation Laboratory CO — Product Code DBF

K040879 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "QUANTEX FERRITIN". The FDA issued a decision of Substantially Equivalent on May 10, 2004. The device falls under product code DBF (Ferritin, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5340. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 2004
Date Received
April 5, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5340
Review Panel
IM
Submission Type