FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
1–24 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 21, 2026
Alegria Flash MPO
K261466 · MOB
Zeus Scientific
Immunology · 109d
Cleared Aug 21, 2026
IDS SS-A/Ro
K253817 · LLL
Immunodiagnostics Systems Limited
Immunology · 266d
Cleared Aug 19, 2026
Elecsys Phospho-Tau (217P) Plasma
K261686 · SET
Roche Diagnostics
Immunology · 90d
Cleared Aug 19, 2026
PrecivityAD2 Test
K253240 · SET
C2N Diagnostics, LLC
Immunology · 324d
Cleared Aug 10, 2026
Atellica IM CA 19-9 II
K253528 · NIG
Siemens Healthcare Diagnostics, Inc.
Immunology · 270d
Cleared Jul 24, 2026
NOVEOS Specific IgE (sIgE)
K261027 · DHB
Hycor Biomedical
Immunology · 116d
Cleared Jul 21, 2026
NOVEOS Specific IgE (sIgE)
K260591 · DHB
Hycor Biomedical
Immunology · 148d
Cleared Jun 25, 2026
EliA CTD 13 Screen
K253367 · LLL
Phadia AB
Immunology · 268d
Cleared Jun 18, 2026
NOVEOS Specific IgE (sIgE)
K260280 · DHB
Hycor Biomedical
Immunology · 140d
Cleared May 15, 2026
NOVEOS Specific IgE (sIgE)
K260059 · DHB
Hycor Biomedical
Immunology · 127d
Cleared May 08, 2026
Alegria Flash SSA-60
K250814 · OBE
Zeus Scientific
Immunology · 417d
Cleared Apr 24, 2026
Diazyme Immunoglobulin A Assay
K252336
Diazyme Laboratories, Inc.
Immunology · 270d
Cleared Feb 06, 2026
Aptiva APS IgA Reagent
K243979 · MSV
Inova Diagnostics, Inc.
Immunology · 410d
Cleared Jan 16, 2026
NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea)
K252775 · DHB
Hycor Biomedical
Immunology · 136d
Cleared Jan 05, 2026
Atellica IM Total PSA II (tPSAII)
K251630 · LTJ
Siemens Healthcare Diagnostics, Inc.
Immunology · 222d
Cleared Dec 23, 2025
NOVEOS Specific IgE (sIgE)
K252493 · DHB
Hycor Biomedical
Immunology · 137d
Cleared Dec 19, 2025
Diazyme Human Kappa (k) Free Light Chain Assay
K253358 · DFH
Diazyme Laboratories, Inc.
Immunology · 80d
Cleared Dec 16, 2025
ADVIA Centaur Cytokeratin Fragment 21-1
K250925 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 264d
Cleared Dec 04, 2025
ADVIA Centaur Anti-Thyroglobulin II (aTgII)
K250816 · JNL
Siemens Healthcare Diagnostics, Inc.
Immunology · 261d
Cleared Oct 22, 2025
Alegria Flash CTD Screen
K250666 · LLL
Zeus Scientific
Immunology · 231d
Cleared Oct 17, 2025
ADVIA Centaur Anti-Thyroid Peroxidase II
K250250 · JZO
Siemens Healthcare Diagnostics, Inc.
Immunology · 262d
Cleared Oct 17, 2025
Immunoglobulin Isotypes (GAM) for the EXENT Analyser
K250159 · SGG
The Binding Site Group , Ltd.
Immunology · 269d
Cleared Oct 08, 2025
Elecsys Phospho-Tau (181P) Plasma
K252163 · SET
Roche Diagnostics
Immunology · 90d
Cleared Sep 19, 2025
Alegria Flash ENA Screen
K250408 · LLL
Zeus Scientific
Immunology · 218d