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

Method, Nephelometric, Immunoglobulins (G, A, M)

21 CFR 866.5510 / Immunology
FDA source (opens on fda.gov)

CFN is the FDA product code for Method, Nephelometric, Immunoglobulins (G, A, M), a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 61 510(k) clearances under this code, the most recent dated , and 20 recalls.

Classification record

Product code
CFN
Device name
Method, Nephelometric, Immunoglobulins (G, A, M)
Regulation
21 CFR 866.5510
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
61
Ingested recalls
20

Clearances, product code CFN

By decision year
61 clearances under product code CFN with a decision year between 1977 and 2023, 2008 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code CFN by decision year
YearClearances
19771
19783
19862
19871
19881
19921
19943
19982
19992
20004
20014
20021
20031
20042
20051
20062
20087
20094
20102
20121
20134
20142
20151
20171
20196
20232

Applicants with the most clearances

Product code CFN
Applicants holding the most 510(k) clearances under product code CFN
ApplicantClearances
The Binding Site15
The Binding Site Group Ltd.14
Siemens Healthcare Diagnostics Inc.12
Antibodies, Inc.3
Crestat Diagnostics, Inc.3
OLYMPUS Corporation of the Americas3
Behring Diagnostics, Inc.2
FUJIFILM Healthcare Americas Corporation2
Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.1
Eiken Chemical Co., Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order