510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DFLClass II

Igm, Ferritin, Antigen, Antiserum, Control

21 CFR 866.5550 / Immunology
FDA source (opens on fda.gov)

DFL is the FDA product code for Igm, Ferritin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DFL
Device name
Igm, Ferritin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5550
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code DFL

By decision year
3 clearances under product code DFL with a decision year between 1978 and 1988, 1988 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DFL by decision year
YearClearances
19781
19882

Applicants with the most clearances

Product code DFL
Applicants holding the most 510(k) clearances under product code DFL
ApplicantClearances
Cyberfluor, Inc.1
Gelman Instrument Co.1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DFL.