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
2113–2136 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST (SM)
K920385 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST KIT
K920386 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
RF STAT IGM TEST KIT
K920753 · DHR
Biowhittaker Molecular Applications,...
Immunology · 40d
Cleared Mar 26, 1992
HUMAN IGG SUBCLASS RID KIT
K915650 · CGM
Janssen Biochimica
Immunology · 99d
Cleared Mar 18, 1992
OPUS FERRITIN TEST SYSTEM
K915838 · DGE
Pb Diagnostic Systems, Inc.
Immunology · 85d
Cleared Mar 18, 1992
ENCORE SCL-70
K920150 · LKJ
Clark Laboratories, Inc.
Immunology · 65d
Cleared Mar 17, 1992
HEMAGEN ENA [RNP/SM] KIT (EIA METHOD)
K915272 · LJM
Hemagen Diagnostics, Inc.
Immunology · 113d
Cleared Mar 17, 1992
DSL ACTIVE BETA2-MICROGLOBULIN (DSL 6500)
K915508 · JZG
Diagnostic Systems Laboratories, Inc.
Immunology · 99d
Cleared Mar 17, 1992
OPUS MYOGLOBIN TEST SYSTEM
K915850 · DDR
Pb Diagnostic Systems, Inc.
Immunology · 82d
Cleared Mar 17, 1992
B2-MICROGLOBULIN RADIOIMMUNOASSAY
K920300 · JZG
Nichols Institute
Immunology · 55d
Cleared Mar 13, 1992
SPECIFIC IGE EIA-TURBO ASSAY
K914554 · DHB
Ventrex Laboratories, Inc.
Immunology · 154d
Cleared Mar 13, 1992
IL TEST IMMUNOGLOBULIN G (IGG)
K920006 · CGM
Instrumentation Laboratory CO
Immunology · 71d
Cleared Mar 13, 1992
IL TEST COMPLEMENT 4
K920010 · DBI
Instrumentation Laboratory CO
Immunology · 71d
Cleared Mar 13, 1992
HEALTHTEST RHEUMATOID FACTOR ASSAY
K920220 · DHR
Akers Research Corp.
Immunology · 57d
Cleared Mar 13, 1992
HEALTHTEST INFECTIOUS MONONUCLEOSIS ASSAY
K920221 · KTN
Akers Research Corp.
Immunology · 57d
Cleared Mar 11, 1992
IL TEST IMMUNOGLOBULIN M (IGM)
K920008 · CGM
Instrumentation Laboratory CO
Immunology · 69d
Cleared Mar 11, 1992
ISOTYPES HUMAN IGG SUBCLASS EIA KIT
K920370 · CGM
Isotypes, Inc.
Immunology · 43d
Cleared Mar 02, 1992
TURBIQUANT
K920124 · DHR
Behring Diagnostics, Inc.
Immunology · 52d
Cleared Feb 21, 1992
VENTREX ALLERGEN DISC
K913833 · DHB
Ventrex Laboratories, Inc.
Immunology · 179d
Cleared Feb 12, 1992
HEMAGEN ENA SCL-70 KIT (EIA METHOD)
K915282 · LLL
Hemagen Diagnostics, Inc.
Immunology · 79d
Cleared Feb 11, 1992
ANTINUCLEAR ANTIBODY IMMUNOGLOBULIN TEST SYSTEM
K914550 · LKJ
Diagnostic Resources, Inc.
Immunology · 123d
Cleared Jan 28, 1992
MODIFIED FERRITIN ENZYME IMUNOASSAY TEST KIT
K920046 · DBF
Medix Biotech, Inc.
Immunology · 22d
Cleared Jan 17, 1992
IL TEST(TM) TRANSFERRIN (TRF)
K914993 · DDG
Instrumentation Laboratory CO
Immunology · 71d
Cleared Jan 17, 1992
COMPLEMENT C1 INACTIVATOR KIT
K915431 · DBA
The Binding Site, Ltd.
Immunology · 46d