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
1705–1728 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jan 24, 1996
CARDIOLIPIN A EIA TEST SYSTEM
K946216 · MID
Hogan & Hartson
Immunology · 399d
Cleared Jan 24, 1996
CARDIOLIPIN M EIA TEST SYSTEM
K946217 · MID
Hogan & Hartson
Immunology · 399d
Cleared Dec 26, 1995
HYTEC AUTOIMMUNE KIT (SS-A)
K954392 · LKJ
Hycor Biomedical, Inc.
Immunology · 98d
Cleared Dec 26, 1995
HYTEC AUTOMMUNE KIT (ENA)
K954890 · LLL
Hycor Biomedical, Inc.
Immunology · 62d
Cleared Dec 26, 1995
HYTEC AUTOIMMUNE KITS (SS-B)
K954891 · LKJ
Hycor Biomedical, Inc.
Immunology · 98d
Cleared Dec 26, 1995
HYTEC AUTOMIMMUNE KIT (RF)
K954892 · DHR
Hycor Biomedical, Inc.
Immunology · 62d
Cleared Dec 21, 1995
ROCHE CONTROL SERUM N
K954655 · JJY
Roche Diagnostic Systems, Inc.
Immunology · 72d
Cleared Dec 21, 1995
ROCHE CONTROL SERUM P
K954656 · JJY
Roche Diagnostic Systems, Inc.
Immunology · 72d
Cleared Dec 20, 1995
WAKO AUTOKIT APO B
K954657 · DFC
Wako Chemicals USA, Inc.
Immunology · 71d
Cleared Dec 20, 1995
TEST, RHEUMATOID FACTOR
K955086 · DHR
Polymedco, Inc.
Immunology · 43d
Cleared Dec 18, 1995
REAADS ANTI-PHOSPHATIDYLSERINE QUANTITATIVE TEST KIT
K952287 · MID
Reaads Medical Products, Inc.
Immunology · 216d
Cleared Dec 18, 1995
WAKO AUTOKIT CH50
K954145 · DAE
Wako Chemicals USA, Inc.
Immunology · 104d
Cleared Dec 18, 1995
C-REACTIVE PROTEIN LATEX KIT
K954447 · DCK
Randox Laboratories, Ltd.
Immunology · 84d
Cleared Dec 18, 1995
SPECIFIC ALLERGEN MODULES FOR THE ALASTAT MICROPLATE ALLERGEN-SPECIFIC IGE...
K954566 · DHB
Diagnostic Products Corp.
Immunology · 77d
Cleared Dec 15, 1995
IMAGETITER INSTRUMENT, ANA TEST KIT & CALIBRATOR SERUM
K952490 · LJM
Roche Image Analysis Systems
Immunology · 199d
Cleared Dec 15, 1995
ENZYME IMMUNOASSAY LUPUS SCREEN TEST KIT
K954700 · LKJ
Helix Diagnostics, Inc.
Immunology · 64d
Cleared Dec 15, 1995
ENZYME IMMUNOASSAY ANA SCREENING TEST KIT
K954723 · LKJ
Helix Diagnostics, Inc.
Immunology · 63d
Cleared Dec 13, 1995
CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM
K955042 · DCN
Shared Systems, Inc.
Immunology · 40d
Cleared Dec 06, 1995
CHEMMATE(TM) LAMBDA
K950149 · DEH
Biotek Solutions, Inc.
Immunology · 323d
Cleared Nov 27, 1995
ANTI-TPO
K954256 · JNL
Biomerica, Inc.
Immunology · 83d
Cleared Nov 20, 1995
THYROGLOBULIN EIA TEST KIT
K951362 · JNL
Immunoprobe, Inc.
Immunology · 241d
Cleared Nov 20, 1995
MICROSOMAL EIA TEST KIT
K951364 · JNL
Immunoprobe, Inc.
Immunology · 241d
Cleared Nov 14, 1995
ACCESS ALLERGEN DOG EPITHELIM
K953780 · DHB
Bio-Rad Laboratories, Inc.
Immunology · 92d
Cleared Nov 14, 1995
ACCESS LOW LEVEL IGE CONTROLS
K953883 · JJX
Bio-Rad Laboratories, Inc.
Immunology · 88d