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

Radioimmunoassay, Parathyroid Hormone

21 CFR 862.1545 / Clinical Chemistry
FDA source (opens on fda.gov)

CEW is the FDA product code for Radioimmunoassay, Parathyroid Hormone, a class II device type, regulated under 21 CFR 862.1545. As of , FDA records hold 86 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
CEW
Device name
Radioimmunoassay, Parathyroid Hormone
Regulation
21 CFR 862.1545
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
86
Ingested recalls
21

Clearances, product code CEW

By decision year
86 clearances under product code CEW with a decision year between 1977 and 2024, 1983 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code CEW by decision year
YearClearances
19772
19793
19813
19823
19835
19844
19853
19861
19872
19881
19891
19902
19911
19922
19932
19942
19954
19962
19973
19992
20002
20014
20023
20031
20044
20054
20064
20074
20101
20121
20132
20141
20151
20172
20191
20231
20242

Applicants with the most clearances

Product code CEW
Applicants holding the most 510(k) clearances under product code CEW
ApplicantClearances
Siemens Healthcare Diagnostics Inc.15
Nichols Institute Diagnostics13
Scantibodies Laboratory Inc.10
Diagnostic Systems Laboratories, Inc.6
Immuno Nuclear Corp.4
Roche Diagnostics GmbH4
Diasorin Inc.3
Immunodiagnostic Systems Ltd.3
Incstar Corp.3
Ortho-Clinical Diagnostics, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order