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
2065–2088 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 18, 1992
QUANTA LITE ENA ELISA
K922829 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
Cleared Sep 18, 1992
QUANTA LITE SS-A ELISA
K922830 · LLL
Inova Diagnostics, Inc.
Immunology · 98d
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