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

Radioimmunoassay, Immunoglobulins (D, E)

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

JHR is the FDA product code for Radioimmunoassay, Immunoglobulins (D, E), a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
JHR
Device name
Radioimmunoassay, Immunoglobulins (D, E)
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
9
Ingested recalls
2

Clearances, product code JHR

By decision year
9 clearances under product code JHR with a decision year between 1984 and 2006, 1990 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JHR by decision year
YearClearances
19841
19871
19881
19902
19931
19961
19991
20061

Applicants with the most clearances

Product code JHR
Applicants holding the most 510(k) clearances under product code JHR
ApplicantClearances
Siemens Healthcare Diagnostics Inc.3
Pharmacia, Inc.2
Boehringer Mannheim Corp.1
Roche Diagnostics GmbH1
Techniclone Intl.1
Ventrex Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code