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

Igm, Antigen, Antiserum, Control

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

DFT is the FDA product code for Igm, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 33 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
DFT
Device name
Igm, 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
33
Ingested recalls
4

Clearances, product code DFT

By decision year
33 clearances under product code DFT with a decision year between 1976 and 1998, 1983 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code DFT by decision year
YearClearances
19763
19772
19791
19803
19813
19835
19842
19851
19862
19873
19882
19891
19901
19941
19962
19981

Applicants with the most clearances

Product code DFT
Applicants holding the most 510(k) clearances under product code DFT
ApplicantClearances
Kallestad Laboratories, Inc.3
Gelco Diagnostics, Inc.2
Icl Scientific2
Isolab, Inc.2
Abbott Medical1
Bartels Immunodiagnostic Supplies, Inc.1
Beckman-Diagnostic Systems Group1
Boehringer Mannheim Corp.1
Calbiochem-Behring Corp.1
E.I. Dupont de Nemours & Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code