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
2737–2760 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Aug 15, 1986
COTTONWOOD ALLERGEN DISC
K862265 · DHB
Immuno Nuclear Corp.
Immunology · 63d
Cleared Aug 15, 1986
PHOTON ELITE/AUTOMATED RANDOM ACCESS IM/CH SYSTEM
K862674 · JZT
Hybritech, Inc.
Immunology · 32d
Cleared Aug 15, 1986
CAPPEL DIAGNOSTICS ANA KIT
K862821 · DHN
Cappel Diagnostics, Inc.
Immunology · 21d
Cleared Aug 15, 1986
JUNE GRASS ALLERGEN DISC
K862938 · DHB
Immuno Nuclear Corp.
Immunology · 11d
Cleared Aug 15, 1986
ORCHARD GRASS ALLERGEN DISC
K862939 · DHB
Immuno Nuclear Corp.
Immunology · 11d
Cleared Aug 06, 1986
TIMOTHY ALLERGEN DISC
K862174 · DGC
Immuno Nuclear Corp.
Immunology · 58d
Cleared Aug 06, 1986
KALLESTAD SM/RNP TEST REAGENT
K862313 · LKJ
Kallestad Laboratories, Inc.
Immunology · 49d
Cleared Aug 04, 1986
IMMUNOCHEMICAL ASSAY OF C-REACTIVE PROTEIN
K860679 · DCN
Orion Corp.
Immunology · 160d
Cleared Jul 29, 1986
KALLESTAD SSA/SSB ENA TEST REAGENTS
K862710 · LLL
Kallestad Laboratories, Inc.
Immunology · 13d
Cleared Jul 18, 1986
ICS APOLIPOPROTEIN A-1 REAGENT TEST KIT
K862019 · MSJ
Beckman Instruments, Inc.
Immunology · 51d
Cleared Jul 18, 1986
ICS APOLIPOPROTEIN B REAGENT TEST KIT
K862386 · MSJ
Beckman Instruments, Inc.
Immunology · 24d
Cleared Jul 07, 1986
ZYGOTEK MICROCOMPUTERIZED SEMEN ANALYSIS SYSTEM
K861773 · DGB
Zygotek Systems, Inc.
Immunology · 61d
Cleared Jul 03, 1986
MONO-LATEX (TM) SLIDE TEST
K862008 · KTN
Armkel, LLC
Immunology · 37d
Cleared Jul 03, 1986
PERENNIAL RYE ALLERGEN DISC
K862173 · DHB
Immuno Nuclear Corp.
Immunology · 24d
Cleared Jul 03, 1986
ENGLISH PLAINTAIN ALLERGEN DISC
K862264 · DHB
Immuno Nuclear Corp.
Immunology · 20d
Cleared Jul 03, 1986
AMPLIFIED ELISA IGE KIT
K862368 · DGC
Allertec, Inc.
Immunology · 9d
Cleared Jun 20, 1986
BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT
K861499 · DAK
Biostar Medical Products, Inc.
Immunology · 58d
Cleared Jun 20, 1986
WHITE OAK ALLERGEN DISC
K862175 · DHB
Immuno Nuclear Corp.
Immunology · 11d
Cleared Jun 10, 1986
DU PONT C-REACTIVE PROTEIN (CRP) CALIBRATOR
K860549 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 117d
Cleared Jun 10, 1986
DU PONT C-REACTIVE PROTEIN (CRP) ASSAY
K860550 · DCK
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 117d
Cleared Jun 10, 1986
AUTOFLUOR V
K861978 · KTL
Technia Diagnostics , Ltd.
Immunology · 20d
Cleared Jun 06, 1986
IMMUNOMEDICS SERUM ELISA TEST SYSTEM
K861362 · CZW
Immunomedics, Inc.
Immunology · 57d
Cleared Jun 06, 1986
VENTREX APO B
K861919 · MSJ
Ventrex Laboratories, Inc.
Immunology · 18d
Cleared May 19, 1986
THE PARTNER SPECTROPHOTOMETER
K861617 · JJQ
Pharmacia, Inc.
Immunology · 20d