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
361–384 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Not Cleared Feb 15, 2012
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE CONTROL, CONJUGATE 50, CALIBRATOR...
DEN120001 · OYL
Phadia US, Inc.
Immunology · 34d
Cleared Jan 24, 2012
AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL
K112705 · JJY
Aalto Scientific, Ltd.
Immunology · 130d
Cleared Jan 20, 2012
ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATOR
K110874 · JZG
Siemens Healthcare Diagnostics, Inc.
Immunology · 297d
Cleared Jan 06, 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523 · DHB
Siemens Healthcare Diagnostics, Inc.
Immunology · 128d
Cleared Dec 27, 2011
ACCESS THYROGLOBULIN ANITBODY
K112933 · JNL
Beckman Coulter, Inc.
Immunology · 85d
Cleared Dec 22, 2011
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
K111919 · DHB
Phadia US, Inc.
Immunology · 168d
Cleared Dec 12, 2011
ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM
K102425 · MID
Zeus Scientific, Inc.
Immunology · 474d
Cleared Dec 02, 2011
IMMULISA SCI-70 ANTIBODY ELISA
K113143 · LLL
Immco Diagnostics, Inc.
Immunology · 38d
Cleared Nov 07, 2011
IT/IF CONTROL
K101863 · JJY
Sebia
Immunology · 493d
Cleared Nov 04, 2011
ACCESS HYBRITECH P2PSA QC ON THE ACCESS IMMUNOASSAY SYSTEMS
K112603 · JJX
Beckman Coulter, Inc.
Immunology · 58d
Cleared Oct 26, 2011
MULTI-ANALYTE DETECTION SYSTEMS
K112810 · NHX
Bio-Rad Laboratories
Immunology · 29d
Cleared Oct 20, 2011
QUANTA FLASH (TM) DGP SCREEN
K111414 · MST
Inova Diagnostics, Inc.
Immunology · 153d
Cleared Oct 13, 2011
IMMUNOFIXATION ELECTROPHORESIS TEST USING INTERLAB G26 INSTRUMENT
K103757 · CFF
Grifols
Immunology · 294d
Cleared Sep 30, 2011
RHEUMATOID FACTOR IMMUNOLOGICAL TEST SYSTEM
K102673 · DHR
Phadia US, Inc.
Immunology · 379d
Cleared Sep 20, 2011
NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY
K101185 · OWM
Iris Molecular Diagnostics
Immunology · 510d
Cleared Sep 01, 2011
ROMA (HE4 EIA + ARCHITECT CA 125 II)
K103358 · ONX
Fujirebio Diagnostics,Inc.
Immunology · 289d
Cleared Aug 18, 2011
AXIS-SHIELD ANTI-CCP
K110296 · NHX
Axis-Shield Diagnostics, Ltd.
Immunology · 198d
Cleared Aug 17, 2011
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · DBF
Siemens Healthcare Diagnostics, Inc.
Immunology · 154d
Cleared Aug 01, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K101572 · DHB
Siemens Healthcare Diagnostics
Immunology · 423d
Cleared Jul 19, 2011
FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL
K103676 · OIU
Fujirebio Diagnostics,Inc.
Immunology · 215d
Cleared Jun 02, 2011
IGX PLEX CELIAC QUALITATIVE ASSAY
K102490 · MVM
Sqi Diagnostics Systems
Immunology · 275d
Cleared Jun 02, 2011
ADVIA CENTAUR CALIBARATOR 80 MODEL 10492491
K103548 · JIT
Siemens Healthcare Diagnostics, Inc.
Immunology · 181d
Cleared May 27, 2011
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE,...
K101251 · DHB
Phadia AB
Immunology · 388d
Cleared May 26, 2011
CYFRA 21-1 EIA MODEL 211-10
K100831 · OVK
Fujirebio Diagnostics,Inc.
Immunology · 428d