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

Iga, Fitc, Antigen, Antiserum, Control

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

CZN is the FDA product code for Iga, Fitc, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CZN
Device name
Iga, Fitc, 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
7
Ingested recalls
0

Clearances, product code CZN

By decision year
7 clearances under product code CZN with a decision year between 1983 and 1989, 1983 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code CZN by decision year
YearClearances
19834
19841
19861
19891

Applicants with the most clearances

Product code CZN
Applicants holding the most 510(k) clearances under product code CZN
ApplicantClearances
Gelco Diagnostics, Inc.2
Dako Corp.1
Helena Laboratories, Corp.1
Intl. Diagnostic Technology1
Kallestad Laboratories, Inc.1
Miles Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code