510(k) K831902

FLUORESCEIN CONJUGATED IMMUNOGLOBIN- by Dako Corp. — Product Code DDZ

K831902 is an FDA 510(k) premarket notification submitted by Dako Corp. for the device "FLUORESCEIN CONJUGATED IMMUNOGLOBIN-". The FDA issued a decision of Substantially Equivalent on July 18, 1983. The device falls under product code DDZ (Albumin, Fitc, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5040. Dako Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1983
Date Received
June 14, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
Review Panel
IM
Submission Type