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

Radioimmunoassay, Free Thyroxine

21 CFR 862.1695 / Clinical Chemistry
FDA source (opens on fda.gov)

CEC is the FDA product code for Radioimmunoassay, Free Thyroxine, a class II device type, regulated under 21 CFR 862.1695. As of , FDA records hold 92 510(k) clearances under this code, the most recent dated , and 12 recalls.

Classification record

Product code
CEC
Device name
Radioimmunoassay, Free Thyroxine
Regulation
21 CFR 862.1695
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
92
Ingested recalls
12

Clearances, product code CEC

By decision year
92 clearances under product code CEC with a decision year between 1977 and 2024, 1993 the highest year at 8.
Show the numbers
510(k) clearances under FDA product code CEC by decision year
YearClearances
19771
19783
19812
19824
19832
19842
19851
19861
19875
19883
19894
19906
19916
19925
19938
19944
19953
19962
19975
19985
20021
20031
20061
20071
20082
20091
20121
20132
20143
20151
20161
20171
20182
20231
20241

Applicants with the most clearances

Product code CEC
Applicants holding the most 510(k) clearances under product code CEC
ApplicantClearances
Siemens Healthcare Diagnostics Inc.11
Abbott Medical8
BD Becton Dickinson Vacutainer Systems Preanalytic8
Amersham Corp.5
Corning Medical & Scientific3
Roche Diagnostics GmbH3
Advanced Magnetics, Inc.2
Bioclinical Group2
bioMerieux, Inc.2
Boehringer Mannheim Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 34 companies shown, in name order