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
1585–1608 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 18, 1996
ORGENTEC ANTI-SM ELISA
K962062 · LJM
American Laboratory Products Co., Ltd.
Immunology · 174d
Cleared Nov 18, 1996
IMMULITE LATEX-SPECIFIC IGE
K963245 · DHB
Diagnostic Products Corp.
Immunology · 91d
Cleared Nov 15, 1996
ORGENTEC ABTI-SS-BB(LA) ELISA
K962052 · LJM
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-JO-1 ELISA
K962053 · LJM
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-SS-A(RO) ELISA
K962054 · LJM
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 15, 1996
ORGENTEC ANTI-SCL 70 ELISA
K962055 · LJM
American Laboratory Products Co., Ltd.
Immunology · 171d
Cleared Nov 07, 1996
DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT
K963525 · DBL
Shield Diagnostics, Ltd.
Immunology · 64d
Cleared Nov 04, 1996
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
K963048 · DHR
Beckman Instruments, Inc.
Immunology · 90d
Cleared Nov 04, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT
K963061 · DCK
Beckman Instruments, Inc.
Immunology · 89d
Cleared Oct 18, 1996
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT
K962409 · CZW
Olympus America, Inc.
Immunology · 119d
Cleared Oct 18, 1996
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT
K962582 · DBI
Olympus America, Inc.
Immunology · 109d
Cleared Oct 10, 1996
SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE...
K961889 · DHB
Diagnostic Products Corp.
Immunology · 147d
Cleared Oct 10, 1996
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY
K962926 · MID
American Laboratory Products Co., Ltd.
Immunology · 73d
Cleared Oct 07, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT
K963286 · DAD
Beckman Instruments, Inc.
Immunology · 47d
Cleared Oct 07, 1996
IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT
K963427 · DDG
Beckman Instruments, Inc.
Immunology · 38d
Cleared Oct 03, 1996
N LATEX B2-MICROGLOBULIN REAGENT
K955596 · JZG
Behring Diagnostics, Inc.
Immunology · 300d
Cleared Sep 30, 1996
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
K962360 · MOB
Scimedx Corp.
Immunology · 103d
Cleared Sep 30, 1996
VARELISA ANA (4) PROFILE
K963291 · LJM
Elias U.S.A., Inc.
Immunology · 40d
Cleared Sep 27, 1996
QUALITROL ANA CONTROL SERUM SET
K961815 · LKJ
Consolidated Technologies, Inc.
Immunology · 140d
Cleared Sep 26, 1996
QUANTEX C4
K962198 · DBI
Instrumentation Laboratory CO
Immunology · 111d
Cleared Sep 26, 1996
QUANTEX IGG
K962202 · DEW
Instrumentation Laboratory CO
Immunology · 111d
Cleared Sep 25, 1996
QUANTEX C3
K962199 · CZW
Instrumentation Laboratory CO
Immunology · 110d
Cleared Sep 25, 1996
QUANTEX IGA
K962200 · CZP
Instrumentation Laboratory CO
Immunology · 110d
Cleared Sep 25, 1996
QUANTEX IGM
K962201 · DFT
Instrumentation Laboratory CO
Immunology · 110d