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

Immunochemical, Thyroglobulin Autoantibody

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

JNL is the FDA product code for Immunochemical, Thyroglobulin Autoantibody, a class II device type, regulated under 21 CFR 866.5870. As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
JNL
Device name
Immunochemical, Thyroglobulin 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
22
Ingested recalls
4

Clearances, product code JNL

By decision year
22 clearances under product code JNL with a decision year between 1990 and 2025, 1995 the highest year at 6.
Show the numbers
510(k) clearances under FDA product code JNL by decision year
YearClearances
19901
19911
19923
19931
19942
19956
19962
19971
20061
20071
20111
20241
20251

Applicants with the most clearances

Product code JNL
Applicants holding the most 510(k) clearances under product code JNL
ApplicantClearances
Siemens Healthcare Diagnostics Inc.4
Immunoprobe, Inc.4
Cogent Diagnotics, Ltd.3
General Biometrics, Inc.2
Hycor Biomedical2
bioMerieux, Inc.2
Biomerica1
Elias U.S.A., Inc.1
Monobind, Inc.1
Nichols Institute1

Companies listing this code with FDA

Companies whose registered establishments list this code