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

Thyroglobulin, Antigen, Antiserum, Control

21 CFR 866.5870 / Immunology
FDA source (opens on fda.gov)

DDC is the FDA product code for Thyroglobulin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5870. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
DDC
Device name
Thyroglobulin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5870
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
13
Ingested recalls
1

Clearances, product code DDC

By decision year
13 clearances under product code DDC with a decision year between 1978 and 2003, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DDC by decision year
YearClearances
19782
19871
19931
19942
19951
19971
19992
20001
20011
20031

Applicants with the most clearances

Product code DDC
Applicants holding the most 510(k) clearances under product code DDC
ApplicantClearances
Zeus Scientific LLC3
Burroughs Wellcome Co.2
Siemens Healthcare Diagnostics Inc.1
Biomerica1
Cogent Diagnotics, Ltd.1
Fujirebio America, Inc.1
Inova Diagnostics, Inc.1
Miles Laboratories, Inc.1
Monobind, Inc.1
Quest Intl., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code