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
1537–1560 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
K962722 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
K962727 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
K962728 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
K962729 · DHR
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
K962730 · LRM
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
K962731 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 06, 1997
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN
K963974 · DEW
Beckman Instruments, Inc.
Immunology · 155d
Cleared Mar 06, 1997
ELIAS ANA-HEP-2
K964385 · LJM
Elias U.S.A., Inc.
Immunology · 122d
Cleared Mar 06, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT
K964843 · JZH
Beckman Instruments, Inc.
Immunology · 93d
Cleared Mar 06, 1997
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT
K965108 · DEW
Beckman Instruments, Inc.
Immunology · 76d
Cleared Mar 06, 1997
ELECSYS CALCHECK CEA
K970452 · JJX
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 06, 1997
ELECSYS CALCHECK PSA
K970458 · JJX
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 06, 1997
ELECSYS CALCHECK CEA
K970459 · JJX
Boehringer Mannheim Corp.
Immunology · 28d
Cleared Mar 04, 1997
AUTOSTATTMII ANTI-DSDNA
K952567 · LRM
Cogent Diagnotics , Ltd.
Immunology · 638d
Cleared Feb 25, 1997
GENZYME DIAGNOSTICS CONTRAST MONO
K963425 · KTN
Genzyme Diagnostics
Immunology · 179d
Cleared Feb 20, 1997
TUMOR MARKER CONTROL
K965114 · JJY
Diagnostic Products Corp.
Immunology · 62d
Cleared Feb 20, 1997
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
K970198 · DHN
Scimedx Corp.
Immunology · 30d
Cleared Feb 14, 1997
VENTANA ANTI-CD4 PRIMARY ANTIBODY
K941604 · DEH
Ventana Medical Systems, Inc.
Immunology · 1050d
Cleared Feb 14, 1997
VENTANA ANTI-CD8 PRIMARY ANTIBODY
K941784 · DEH
Ventana Medical Systems, Inc.
Immunology · 1040d
Cleared Feb 10, 1997
ANTI-VIMENTIN PRIMARY ANTIBODY
K941397 · DEH
Ventana Medical Systems, Inc.
Immunology · 1056d
Cleared Feb 10, 1997
VENTANNA ANTI-DESMIN PRIMARY ANTIBODY
K941516 · DEH
Ventana Medical Systems, Inc.
Immunology · 1049d
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
K963868 · DEW
Beckman Instruments, Inc.
Immunology · 137d
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM APOLIPOPROTEIN A-1 REAGENT (APA)/ IMMAGE...
K964010 · MSJ
Beckman Instruments, Inc.
Immunology · 126d
Cleared Feb 10, 1997
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE...
K964260 · DFH
Beckman Instruments, Inc.
Immunology · 108d