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

Radioimmunoassay, Thyroxine-Binding Globulin

21 CFR 862.1685 / Clinical Chemistry
FDA source (opens on fda.gov)

CEE is the FDA product code for Radioimmunoassay, Thyroxine-Binding Globulin, a class II device type, regulated under 21 CFR 862.1685. As of , FDA records hold 25 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
CEE
Device name
Radioimmunoassay, Thyroxine-Binding Globulin
Regulation
21 CFR 862.1685
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
25
Ingested recalls
1

Clearances, product code CEE

By decision year
25 clearances under product code CEE with a decision year between 1976 and 1995, 1978 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CEE by decision year
YearClearances
19761
19772
19783
19801
19811
19822
19843
19862
19871
19881
19892
19902
19912
19931
19951

Applicants with the most clearances

Product code CEE
Applicants holding the most 510(k) clearances under product code CEE
ApplicantClearances
Boehringer Mannheim Corp.3
Nuclear Diagnostics, Inc.3
IMMUNOTECH s.r.o.2
Amersham Corp.1
Bio-Rad1
Bio-Rad Laboratories Inc.1
Cirrus Diagnostics, Inc.1
Clinical Assays, Inc.1
Corning Medical & Scientific1
Cyberfluor, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code