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
1585–1608 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 25, 1996
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
K962452 · DBM
Hycor Biomedical, Inc.
Immunology · 160d
Cleared Nov 18, 1996
ORGENTEC ANTI-RNP/SM ELISA
K962057 · LJM
American Laboratory Products Co., Ltd.
Immunology · 174d
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