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

System, Test, Thyroid Autoantibody

21 CFR 866.5870 / Immunology
FDA source (opens on fda.gov)

JZO is the FDA product code for System, Test, Thyroid Autoantibody, a class II device type, regulated under 21 CFR 866.5870. As of , FDA records hold 92 510(k) clearances under this code, the most recent dated , and 18 recalls.

Classification record

Product code
JZO
Device name
System, Test, Thyroid Autoantibody
Regulation
21 CFR 866.5870
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
92
Ingested recalls
18

Clearances, product code JZO

By decision year
92 clearances under product code JZO with a decision year between 1976 and 2025, 1993 the highest year at 9.
Show the numbers
510(k) clearances under FDA product code JZO by decision year
YearClearances
19761
19791
19811
19821
19842
19861
19872
19881
19892
19901
19911
19925
19939
19958
19962
19972
19987
19998
20007
20014
20024
20032
20042
20051
20065
20082
20092
20101
20162
20201
20232
20241
20251

Applicants with the most clearances

Product code JZO
Applicants holding the most 510(k) clearances under product code JZO
ApplicantClearances
American Laboratory Products Company9
Siemens Healthcare Diagnostics Inc.9
Roche Diagnostics GmbH7
Brahms Diagnostica, LLC5
Elias U.S.A., Inc.5
Kronus, Inc.4
Pharmacia & Upjohn Company LLC4
Axis-Shield Diagnostics, Ltd.3
Zeus Scientific LLC3
Cogent Diagnotics, Ltd.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 30 companies shown, in name order