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
2017–2040 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 14, 1993
ELIAS TGAB
K925922 · JZO
Elias U.S.A., Inc.
Immunology · 52d
Cleared Jan 14, 1993
ELIAS TMAB
K925923 · JZO
Elias U.S.A., Inc.
Immunology · 52d
Cleared Jan 13, 1993
IMMULITE FERRITIN
K925848 · JMG
Diagnostic Products Corp.
Immunology · 56d
Cleared Jan 13, 1993
ACCESS FERRITIN ASSAY
K926221 · JMG
Bio-Rad Laboratories, Inc.
Immunology · 34d
Cleared Dec 29, 1992
ENA SCREENING CIE KIT FOR DIAGNOSTIC USE
K924262 · LLL
The Binding Site, Ltd.
Immunology · 127d
Cleared Dec 23, 1992
ENCORE DS-DNA
K923537 · LRM
Clark Laboratories, Inc.
Immunology · 160d
Cleared Dec 23, 1992
LPIA-FERRITIN ASSAY
K924186 · DEF
Seradyn, Inc.
Immunology · 125d
Cleared Dec 23, 1992
NICHOLS APO B CHEMILUMINESCENCE ASSAY
K925702 · MSJ
Nichols Institute Diagnostics
Immunology · 41d
Cleared Dec 15, 1992
ZORBA(TM) IGG REMOVAL REAGENT
K924197 · DEW
Zeus Scientific, Inc.
Immunology · 117d
Cleared Dec 15, 1992
AIA-PACK FER CALIBRATION VERIFICATION TEST SET
K924858 · DBF
Tosoh Medics, Inc.
Immunology · 78d
Cleared Dec 15, 1992
QUANTA LITE(TM) SCL-70 ELISA
K924898 · LLL
Inova Diagnostics, Inc.
Immunology · 78d
Cleared Dec 07, 1992
RHEUMA-LEX(TM) SYST: RHEUMATOID FACTOR LATEX TEST
K915320 · DHR
Trinity Laboratories, Inc.
Immunology · 381d
Cleared Dec 07, 1992
ACCUTEX CRP LATEX TEST
K924332 · DCK
J.S. Medical Assoc.
Immunology · 102d
Cleared Dec 01, 1992
SYN ELISA DSDNA ANTIBODIES
K921132 · LKJ
Elias U.S.A., Inc.
Immunology · 266d
Cleared Dec 01, 1992
ENCORE SM
K921572 · LLL
Clark Laboratories, Inc.
Immunology · 243d
Cleared Dec 01, 1992
ENCORE SM/RNP
K921870 · LLL
Clark Laboratories, Inc.
Immunology · 225d
Cleared Dec 01, 1992
PULSE CRP TEST
K923768 · DCK
Pulse Scientific, Inc.
Immunology · 126d
Cleared Dec 01, 1992
ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST
K924036 · DHR
J.S. Medical Assoc.
Immunology · 112d
Cleared Dec 01, 1992
VENTREX ALLERGEN DISC
K924044 · DHB
Hycor Biomedical, Inc.
Immunology · 112d
Cleared Dec 01, 1992
IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL
K924843 · LLL
General Biometrics, Inc.
Immunology · 64d
Cleared Nov 30, 1992
AUTOZYME
K922241 · LLL
Cambridge Life Sciences Plc.
Immunology · 201d
Cleared Nov 30, 1992
VENTREX ALLERGEN DISC
K924119 · DHB
Ventrex, Inc.
Immunology · 108d
Cleared Nov 30, 1992
VENTREX ALLERGEN DISC
K924209 · DHB
Hycor Biomedical, Inc.
Immunology · 102d
Cleared Nov 30, 1992
SYNELISA CARDIOLIPIN ANTIBODIES
K924421 · MID
Elias U.S.A., Inc.
Immunology · 90d