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
2065–2088 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 18, 1992
QUANTA LITE SM ELISA
K922831 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-B ELISA
K922832 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE RNP ELISA
K922833 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 14, 1992
866.5750 RADIOALLERGOSORBENT IMMUNLOGICAL TEST SYS
K914685 · DHB
In Vitro Technologies, Inc.
Immunology · 332d
Cleared Sep 14, 1992
IGE EIA TEST KIT
K920087 · DGO
The Binding Site, Ltd.
Immunology · 250d
Cleared Aug 20, 1992
MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM
K914959 · DHB
Ciba Corning Diagnostics Corp.
Immunology · 289d
Cleared Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST
K920400 · MID
General Biometrics, Inc.
Immunology · 204d
Cleared Aug 20, 1992
IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST
K920401 · MID
General Biometrics, Inc.
Immunology · 204d
Cleared Aug 20, 1992
AL-ACID GLYCOPROTEIN RID KIT
K922417 · LKL
The Binding Site, Ltd.
Immunology · 91d
Cleared Aug 20, 1992
WAKO IGG-HA
K923070 · CFN
Wako Chemicals USA, Inc.
Immunology · 56d
Cleared Aug 05, 1992
IGE ENZYME IMMUNOASSAY TEST KIT CAT.NO. KIF4064
K922047 · DGC
Medix Biotech, Inc.
Immunology · 96d
Cleared Aug 03, 1992
DIASTAT ANTI-CARDIOLIPIN KIT
K921265 · MID
Shield Diagnostics, Ltd.
Immunology · 140d
Cleared Aug 03, 1992
WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC
K921574 · DHB
Hycor Biomedical, Inc.
Immunology · 123d
Cleared Jul 29, 1992
IL TEST(TM) HAPTOGLOBIN (HPT)
K915829 · DAD
Instrumentation Laboratory CO
Immunology · 212d
Cleared Jul 29, 1992
IL TEST ALPHA-1-ANTITRYPSIN (AAT)
K920005 · DEM
Instrumentation Laboratory CO
Immunology · 209d
Cleared Jul 28, 1992
SYNELISA TPO ANTIBODIES
K921787 · JNL
Elias U.S.A., Inc.
Immunology · 105d
Cleared Jul 28, 1992
WAKO AUTOKIT RF
K922151 · DHR
Wako Chemicals USA, Inc.
Immunology · 82d
Cleared Jul 27, 1992
VENTREX ALLERGEN DISC
K922538 · DHB
Hycor Biomedical, Inc.
Immunology · 59d
Cleared Jul 21, 1992
STRATUS MYOGLOBIN FLUOROMETRIC ENZYME IMMUNOASSAY
K922125 · DDR
Baxter Diagnostics, Inc.
Immunology · 76d
Cleared Jul 15, 1992
DADE(R) MYOGLOBIN CONTROLS TRI-LEVEL
K922387 · DDR
Baxter Diagnostics, Inc.
Immunology · 56d
Cleared Jul 14, 1992
DIASTAT ANTI-HISTONE KIT
K920616 · LJM
Shield Diagnostics, Ltd.
Immunology · 154d
Cleared Jul 14, 1992
IMFECTIOUS MONONUCLEOSIS IM LIQUID CARD TEST
K922296 · KTN
Ampcor, Inc.
Immunology · 60d
Cleared Jul 14, 1992
INFECTIOUS MONONUCLEOSIS QIK-DOT IM DRY CARD TEST
K922297 · KTN
Ampcor, Inc.
Immunology · 60d
Cleared Jun 23, 1992
BACTON(TM), AUTO-APO A-1 REAGENT
K921795 · MSJ
Bacton Assay Systems, Inc.
Immunology · 74d