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

System, Test, Carcinoembryonic Antigen

21 CFR 866.6010 / Immunology
FDA source (opens on fda.gov)

DHX is the FDA product code for System, Test, Carcinoembryonic Antigen, a class II device type, regulated under 21 CFR 866.6010. As of , FDA records hold 28 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
DHX
Device name
System, Test, Carcinoembryonic Antigen
Regulation
21 CFR 866.6010
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
28
Ingested recalls
9

Clearances, product code DHX

By decision year
28 clearances under product code DHX with a decision year between 1980 and 2023, 1981 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DHX by decision year
YearClearances
19802
19814
19821
19841
19871
19931
19971
19984
19993
20011
20021
20031
20041
20082
20091
20201
20232

Applicants with the most clearances

Product code DHX
Applicants holding the most 510(k) clearances under product code DHX
ApplicantClearances
Siemens Healthcare Diagnostics Inc.6
Ortho-Clinical Diagnostics, Inc.3
Tosoh Medics, Inc.2
Abbott Medical1
Amicon, Inc.1
Bayer Corp.1
BD Becton Dickinson Vacutainer Systems Preanalytic1
Beckman1
Biosan Laboratories, Inc.1
Boehringer Mannheim Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 19 companies shown, in name order