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
2497–2520 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 21, 1988
HEART CHECK APOLIPOPROTEIN-B
K881433 · MSJ
Northwest Biotech
Immunology · 16d
Cleared Apr 21, 1988
HEART CHECK APOLIPOPROTEIN A-1
K881434 · MSJ
Northwest Biotech
Immunology · 16d
Cleared Apr 21, 1988
IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS
K881675 · JZQ
Dynatech Laboratories, Inc.
Immunology · 3d
Cleared Apr 07, 1988
IVT CENTRAL ALLERGY SCREEN
K875329 · DHB
In Vitro Technologies, Inc.
Immunology · 99d
Cleared Apr 07, 1988
N PROTEIN STANDARD PLASMA (HUMAN)
K880356 · CFN
Behring Diagnostics, Inc.
Immunology · 72d
Cleared Apr 07, 1988
MONO-PHILE
K881247 · KTN
Bio Diagnostic Systems, Inc.
Immunology · 15d
Cleared Apr 06, 1988
QUIDEL ALLERGY SCREEN
K874717 · DHB
Quidel Corp.
Immunology · 141d
Cleared Apr 06, 1988
SM ANTIBODY TEST KIT
K880254 · LKP
Lipogen, Inc.
Immunology · 77d
Cleared Apr 06, 1988
QM300 ALBUMIN ANTIBODY PACK
K881126 · DCF
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 21d
Cleared Apr 06, 1988
NOVA GEL(TM) SM/RNP
K881181 · LLL
Inova Diagnostics, Inc.
Immunology · 35d
Cleared Mar 30, 1988
KALLESTAD QM300 CALIBRATOR C PACK
K880729 · DCK
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 36d
Cleared Mar 29, 1988
WAKO(TM) IGA-HA DIRECT
K880803 · CZP
Wako Chemicals USA, Inc.
Immunology · 29d
Cleared Mar 25, 1988
VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY
K880547 · DHB
Ventrex Laboratories, Inc.
Immunology · 45d
Cleared Mar 25, 1988
KALLESTAD QM300 C-REACTIVE PROTEIN ANTIBODY PACK
K880728 · DCN
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 31d
Cleared Mar 25, 1988
KALLESTAD QM2/QM300 CONTROL C PACK
K880730 · DCK
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 31d
Cleared Mar 25, 1988
NOVA LITE(TM) ANA
K880736 · LLL
Inova Diagnostics, Inc.
Immunology · 30d
Cleared Mar 25, 1988
NOVA LITE(TM) DSDNA
K880742 · DHN
Inova Diagnostics, Inc.
Immunology · 30d
Cleared Mar 25, 1988
WAKO(TM) IGM-HA DIRECT
K880828 · DFT
Wako Chemicals USA, Inc.
Immunology · 24d
Cleared Mar 25, 1988
NOVA GEL(TM) SS-A/SS-B
K880896 · LLL
Inova Diagnostics, Inc.
Immunology · 23d
Cleared Mar 23, 1988
IVT WESTERN ALLERGY SCREEN
K875328 · DHB
In Vitro Technologies, Inc.
Immunology · 84d
Cleared Mar 21, 1988
VISION(R) CRP
K875345 · DCK
Abbott Laboratories
Immunology · 82d
Cleared Mar 18, 1988
QUIDEL TOTAL IGE TEST
K875168 · DHB
Quidel Corp.
Immunology · 93d
Cleared Mar 11, 1988
RNP ANTIBODY TEST KIT
K874152 · LKO
Lipogen, Inc.
Immunology · 150d
Cleared Mar 11, 1988
LA ANTIBODY TEST KIT
K874195 · LJM
Lipogen, Inc.
Immunology · 149d