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
1705–1728 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Nov 14, 1995
THERATEST LAB, INC., EL-ANASCR KIT
K954106 · LJM
Theratest Laboratories, Inc.
Immunology · 105d
Cleared Nov 09, 1995
ORGEN TEC ANTI-DSDNA ELISA ASSAY
K953671 · LRM
Orgentec
Immunology · 94d