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

Complement C3, Antigen, Antiserum, Control

21 CFR 866.5240 / Immunology
FDA source (opens on fda.gov)

CZW is the FDA product code for Complement C3, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5240. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
CZW
Device name
Complement C3, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
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
44
Ingested recalls
1

Clearances, product code CZW

By decision year
44 clearances under product code CZW with a decision year between 1976 and 2010, 1985 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code CZW by decision year
YearClearances
19761
19781
19791
19802
19812
19832
19841
19853
19861
19873
19893
19901
19911
19921
19951
19963
19972
19981
19993
20002
20012
20031
20042
20051
20061
20071
20101

Applicants with the most clearances

Product code CZW
Applicants holding the most 510(k) clearances under product code CZW
ApplicantClearances
Siemens Healthcare Diagnostics Inc.4
Behring Diagnostics, Inc.2
Dako Corp.2
Diamedix Corp.2
Instrumentation Laboratory Co.2
The Binding Site2
Abbott Medical1
Antibodies, Inc.1
Applications Lab1
Bayer Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order