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
2017–2040 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Nov 25, 1992
PHARMACIA CAP SYSTEM IGE FEIA -- MODIFICATION
K923832 · DGC
Kabi Pharmacia, Inc.
Immunology · 120d
Cleared Nov 06, 1992
MYOGLOBIN ELISA TEST KIT
K923195 · DDR
Immuno Diagnostic Center, Inc.
Immunology · 129d