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DES – Lambda, Fitc, Antigen, Antiserum, Control
Lambda, Fitc, Antigen, Antiserum, Control
FDA product code
DES
· Class II (moderate risk) · 21 CFR 866.5550 ·
Immunology
2
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Dako Corp.
1
Gelco Diagnostics, Inc.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K832267
Fitc Goat Anti-Human Lamba
DES · Traditional
Gelco Diagnostics, Inc.
10/31/1983
SE
K831903
Fluorescein Conjugated Immunoglobulin
DES · Traditional
Dako Corp.
07/19/1983
SE