Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
1537–1560 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
K962719 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
Cleared Mar 07, 1997
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720 · LLL
Hycor Biomedical, Inc.
Immunology · 249d
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