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
2113–2136 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 30, 1992
ANTI-ENA ANTIBODY TEST [SS-A (RO)]
K920383 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
Cleared Mar 30, 1992
ANIT-ENA ANTIBODY TEST [SS-B (LA)]
K920384 · LLL
Immco Diagnostics, Inc.
Immunology · 60d
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