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DFL – Igm, Ferritin, Antigen, Antiserum, Control
Igm, Ferritin, Antigen, Antiserum, Control
FDA product code
DFL
· Class II (moderate risk) · 21 CFR 866.5550 ·
Immunology
3
510(k) clearances
0
PMA approvals
0
recalls
Manufacturers
Gelman Instrument Co.
1
Cyberfluor, Inc.
1
Technicon Instruments Corp.
1
510(k) clearances
510(k)
Device
Applicant
Decision
K883493
Technicon DPA-1 Immunoglobulin M
DFL · Traditional
Technicon Instruments Corp.
09/22/1988
SE
K882822
Fiagen Ferritin
DFL · Traditional
Cyberfluor, Inc.
08/04/1988
SE
K772079
Radial Immunodiffusion Kit-Immunoglob.M
DFL · Traditional
Gelman Instrument Co.
02/03/1978
SE