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

System, Test, Beta-2-Microglobulin Immunological

21 CFR 866.5630 / Immunology
FDA source (opens on fda.gov)

JZG is the FDA product code for System, Test, Beta-2-Microglobulin Immunological, a class II device type, regulated under 21 CFR 866.5630. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 6 recalls.

Classification record

Product code
JZG
Device name
System, Test, Beta-2-Microglobulin Immunological
Regulation
21 CFR 866.5630
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
53
Ingested recalls
6

Clearances, product code JZG

By decision year
53 clearances under product code JZG with a decision year between 1984 and 2016, 1991 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code JZG by decision year
YearClearances
19842
19851
19861
19881
19893
19905
19917
19924
19932
19941
19953
19964
19973
19982
19992
20002
20021
20041
20051
20072
20092
20122
20161

Applicants with the most clearances

Product code JZG
Applicants holding the most 510(k) clearances under product code JZG
ApplicantClearances
Siemens Healthcare Diagnostics Inc.8
The Binding Site6
Pharmacia, Inc.5
Behring Diagnostics, Inc.3
Diagnostic Systems Laboratories, Inc.3
Abbott Medical2
Bayer Corp.2
Beckman Instruments, Inc.2
Biokit, S.A.2
Beckman Coulter Ireland Inc1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order