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

Factor B, Antigen, Antiserum, Control

21 CFR 866.5320 / Immunology
FDA source (opens on fda.gov)

JZH is the FDA product code for Factor B, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5320. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
JZH
Device name
Factor B, Antigen, Antiserum, Control
Regulation
21 CFR 866.5320
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
6
Ingested recalls
1

Clearances, product code JZH

By decision year
6 clearances under product code JZH with a decision year between 1978 and 1997, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JZH by decision year
YearClearances
19782
19811
19831
19881
19971

Applicants with the most clearances

Product code JZH
Applicants holding the most 510(k) clearances under product code JZH
ApplicantClearances
Beckman Instruments, Inc.1
Hyland Therapeutic Div., Travenol Laboratories1
Icl Scientific1
Kallestad Laboratories, Inc.1
Kent Laboratories, Inc.1
Technicon Instruments Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code