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

System, Test, Radioallergosorbent (Rast) Immunological

21 CFR 866.5750 / Immunology
FDA source (opens on fda.gov)

DHB is the FDA product code for System, Test, Radioallergosorbent (Rast) Immunological, a class II device type, regulated under 21 CFR 866.5750. As of , FDA records hold 268 510(k) clearances under this code, the most recent dated , and 27 recalls.

Classification record

Product code
DHB
Device name
System, Test, Radioallergosorbent (Rast) Immunological
Regulation
21 CFR 866.5750
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
269
Ingested recalls
27

Clearances, product code DHB

By decision year
269 clearances under product code DHB with a decision year between 1977 and 2026, 1988 the highest year at 33.
Show the numbers
510(k) clearances under FDA product code DHB by decision year
YearClearances
19771
19801
19812
19824
198311
198411
198511
198625
198732
198833
198912
19909
199114
199210
19933
19945
199511
19965
19974
19984
19992
20001
20012
20024
20031
20051
20061
20071
20082
20097
20103
20115
20123
20135
20141
20151
20162
20171
20182
20193
20202
20211
20222
20252
20266

Applicants with the most clearances

Product code DHB
Applicants holding the most 510(k) clearances under product code DHB
ApplicantClearances
Pharmacia, Inc.39
Siemens Healthcare Diagnostics Inc.37
Incstar Corp.25
Hycor Biomedical24
Phadia AB20
Ventrex Laboratories, Inc.18
Immuno Nuclear Corp.14
Mast Immunosystems10
Ortho-Clinical Diagnostics, Inc.9
3M Company8

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order