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

Iga, Rhodamine, Antigen, Antiserum, Control

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

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

Classification record

Product code
CZK
Device name
Iga, Rhodamine, 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
1
Ingested recalls
0

Clearances, product code CZK

By decision year
1 clearance under product code CZK with a decision year between 1984 and 1984, 1984 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CZK by decision year
YearClearances
19841

Applicants with the most clearances

Product code CZK
Applicants holding the most 510(k) clearances under product code CZK
ApplicantClearances
Instrumentation Laboratory Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code