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
2497–2520 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 21, 1988
CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
K881138 · JMG
Baxter Healthcare Corp
Immunology · 36d
Cleared Apr 21, 1988
NOVA LITE(TM) ANA PLUS
K881339 · LLL
Inova Diagnostics, Inc.
Immunology · 23d
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