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

Iga, Antigen, Antiserum, Control

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

CZP is the FDA product code for Iga, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5510. As of , FDA records hold 54 510(k) clearances under this code, the most recent dated , and 3 recalls.

Classification record

Product code
CZP
Device name
Iga, 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
54
Ingested recalls
3

Clearances, product code CZP

By decision year
54 clearances under product code CZP with a decision year between 1976 and 2020, 1981 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code CZP by decision year
YearClearances
19761
19773
19781
19793
19803
19816
19823
19832
19843
19853
19866
19872
19883
19892
19901
19921
19931
19951
19963
19981
20001
20031
20041
20061
20201

Applicants with the most clearances

Product code CZP
Applicants holding the most 510(k) clearances under product code CZP
ApplicantClearances
Abbott Medical3
Boehringer Mannheim Corp.3
Kallestad Laboratories, Inc.3
Atlantic Antibodies2
Siemens Healthcare Diagnostics Inc.2
E.I. Dupont de Nemours & Co., Inc.2
Helena Laboratories, Corp.2
Icl Scientific2
Instrumentation Laboratory Co.2
Syva Co.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order