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

Igd, Antigen, Antiserum, Control

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

CZJ is the FDA product code for Igd, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CZJ
Device name
Igd, Antigen, Antiserum, Control
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
8
Ingested recalls
0

Clearances, product code CZJ

By decision year
8 clearances under product code CZJ with a decision year between 1978 and 2009, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CZJ by decision year
YearClearances
19781
19831
19871
19881
19911
20001
20051
20091

Applicants with the most clearances

Product code CZJ
Applicants holding the most 510(k) clearances under product code CZJ
ApplicantClearances
The Binding Site4
Helena Laboratories, Corp.1
Hyland Therapeutic Div., Travenol Laboratories1
Kallestad Diag, A Div. of Erbamont, Inc.1
Kent Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code