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

Hemopexin, Antigen, Antiserum, Control

21 CFR 866.5490 / Immunology
FDA source (opens on fda.gov)

CZX is the FDA product code for Hemopexin, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5490. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
CZX
Device name
Hemopexin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5490
Device class
Class II
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code CZX

By decision year
3 clearances under product code CZX with a decision year between 1978 and 1980, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code CZX by decision year
YearClearances
19781
19791
19801

Applicants with the most clearances

Product code CZX
Applicants holding the most 510(k) clearances under product code CZX
ApplicantClearances
J.T. Baker Chemical Co.1
Kallestad Laboratories, Inc.1
Kent Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code