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
1321–1344 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 24, 1998
ELECSYS MYOGLOBIN STAT ASSAY
K983176 · DDR
Boehringer Mannheim Corp.
Immunology · 14d
Cleared Sep 18, 1998
IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5
K981297 · LTK
Diagnostic Products Corp.
Immunology · 163d
Cleared Sep 17, 1998
ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT
K982121 · DBM
Trace Scientific , Ltd.
Immunology · 93d
Cleared Sep 15, 1998
ALLERGEN IMMUNOCAP MODELS D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48,...
K982343 · DHB
Pharmacia & Upjohn Co.
Immunology · 71d
Cleared Sep 04, 1998
PELICALSS HUMAN IGG SUBCLASS NEPHLOMETRIC ARRAY KIT
K982023 · DAS
Inova Diagnostics, Inc.
Immunology · 87d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG
K981644 · MST
The Binding Site, Ltd.
Immunology · 118d
Cleared Sep 03, 1998
BINDAZYME ANTIGLIADIN IGG/IGA COMBI KIT
K981929 · MST
The Binding Site, Ltd.
Immunology · 118d
Cleared Aug 27, 1998
QUANTA LITE TTG (TISSUE TRANSGLUTAMINASE) ELISA
K982366 · MVM
Inova Diagnostics, Inc.
Immunology · 51d
Cleared Aug 18, 1998
ROCHE CRP T CONTROL N
K982087 · DCK
Roche Diagnostic Systems, Inc.
Immunology · 64d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/4
K982150 · LLL
Theratest Laboratories, Inc.
Immunology · 56d
Cleared Aug 13, 1998
EL-ANA PROFILES: EL-ENA/5
K982622 · LLL
Theratest Laboratories, Inc.
Immunology · 56d
Cleared Aug 12, 1998
ACS:CENTAUR CEA
K981478 · DHX
Chiron Diagnostics Corp.
Immunology · 110d
Cleared Aug 12, 1998
ACS:CENTAUR PSA2 IMMUNOASSAY
K981839 · LTJ
Chiron Diagnostics Corp.
Immunology · 78d
Cleared Aug 12, 1998
TUMOR MARKER CONTROL
K982473 · JJY
Diagnostic Products Corp.
Immunology · 27d
Cleared Aug 12, 1998
IMMULITE PSA CONTROL MODULE, MODEL LPSCM
K982637 · JJY
Diagnostic Products Corp.
Immunology · 14d
Cleared Aug 03, 1998
ACTIVE PSA ELISA (DSL-10-9700)
K973243 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Aug 03, 1998
ACTIVE PSA IRMA (DSL-9700)
K973244 · LTJ
Diagnostic Systems Laboratories, Inc.
Immunology · 339d
Cleared Jul 29, 1998
QUIDEL CH50 EQ EIA
K974111 · DAE
Quidel Corp.
Immunology · 271d
Cleared Jul 29, 1998
QUANTA LITE TPO ELISA
K981857 · LLL
Inova Diagnostics, Inc.
Immunology · 63d
Cleared Jul 22, 1998
WIELISA ANCA SCREENING KIT TEST SYSTEM
K981748 · MOB
Wieslab AB
Immunology · 65d
Cleared Jul 22, 1998
WIELISA ANTI-GBM, ANCA SCREENING KIT TEST SYSTEM
K981750 · MOB
Wieslab AB
Immunology · 65d
Cleared Jul 20, 1998
BINDAZYME ANTI-PR3 ENZYME IMMUNOASSAY KIT
K981029 · MOB
The Binding Site, Ltd.
Immunology · 123d
Cleared Jul 20, 1998
BINDAZYME ANTI-MPO ENZYME IMMUNOASSAY KIT
K981030 · MOB
The Binding Site, Ltd.
Immunology · 123d
Cleared Jul 10, 1998
ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANTITATION OF CANCER...
K981698 · MOI
Chiron Corp.
Immunology · 57d