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

Kappa, Antigen, Antiserum, Control

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

DFH is the FDA product code for Kappa, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5550. As of , FDA records hold 63 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
DFH
Device name
Kappa, 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
63
Ingested recalls
2

Clearances, product code DFH

By decision year
63 clearances under product code DFH with a decision year between 1978 and 2025, 1982 the highest year at 15.
Show the numbers
510(k) clearances under FDA product code DFH by decision year
YearClearances
19782
19792
19801
19812
198215
19832
19842
19861
19884
19901
19952
19971
20001
20011
20031
20041
20052
20072
20081
20091
20131
20151
20161
20171
20183
20191
20212
20224
20242
20252

Applicants with the most clearances

Product code DFH
Applicants holding the most 510(k) clearances under product code DFH
ApplicantClearances
Amico Lab, Inc.14
The Binding Site8
Siemens Healthcare Diagnostics Products Limited6
Diazyme Laboratories, Inc.5
Beckman Instruments, Inc.4
The Binding Site Group Ltd.4
Biotek Solutions, Inc.2
Dako Corp.2
Gelco Diagnostics, Inc.2
Icl Scientific2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order