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
313–336 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jun 28, 2013
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP...
K123275 · DHB
Phadia AB
Immunology · 252d
Cleared Jun 19, 2013
HUMAN ALBUMIN CSF KIT
K121045 · DCF
The Binding Site Group , Ltd.
Immunology · 439d
Cleared Jun 19, 2013
RANDOX SPECIALITY CONTROL (I) LEVELS 1, 2 AND 3
K130337 · JJY
Randox Laboratories Limited
Immunology · 128d
Cleared Jun 14, 2013
VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406
K123127 · JJX
Maine Standards Co.
Immunology · 253d
Cleared Jun 12, 2013
EUROIMMUN ANTI-NRNP/SM ELISA (IGG)
K123261 · LKO
Euroimmun US
Immunology · 237d
Cleared Jun 03, 2013
HUMAN CAERULOPLASMIN KIT
K122965 · DDB
The Binding Site Group , Ltd.
Immunology · 252d
Cleared May 30, 2013
HUMAN IGA CSF KIT FOR USE ON SPAPLUS
K120901 · CFN
The Binding Site Group , Ltd.
Immunology · 430d
Cleared May 29, 2013
FREND PSA PLUS (REAGENT CARTRIDGE)
K124056 · LTJ
Nanoentek, Inc.
Immunology · 149d
Cleared May 17, 2013
HUMAN IGG CSF KIT
K120749 · CFN
The Binding Site Group , Ltd.
Immunology · 431d
Cleared May 17, 2013
HUMAN IGM CSF KIT
K120750 · CFN
The Binding Site Group , Ltd.
Immunology · 431d
Cleared May 07, 2013
QUANTA FLASH ENA7
K122923 · LLL
Inova Diagnostics, Inc.
Immunology · 225d
Cleared Apr 17, 2013
QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH...
K123593 · LKP
Inova Diagnostics, Inc.
Immunology · 147d
Cleared Apr 15, 2013
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
K122304 · DBA
The Binding Site Group , Ltd.
Immunology · 257d
Cleared Apr 12, 2013
EUROIMMUN EUROLINE PROFILE AUTOIMMUNE LIVER DISEASE 8AG (IGG)
K113439 · NIY
Euroimmun US
Immunology · 508d
Cleared Apr 12, 2013
LIQUICHEK IMMUNOLOGY CONTROL, LEVEL 1,2,3, TRILEVEL MINIPAK
K130761 · JJY
Bio-Rad Laboratories
Immunology · 23d
Cleared Apr 09, 2013
EUROIMMUN ANTI-ENA POOL ELISA (IGG)
K112996 · LLL
Euroimmun US
Immunology · 550d
Cleared Apr 04, 2013
IMMULITE 2000 ANTI-CCP IGG ASSAY
K121576 · NHX
Siemens Healthcare Diagnostics, Inc.
Immunology · 309d
Cleared Apr 01, 2013
HUMAN KAPPA AND LAMBDA FREE KITFOR USE ON THE SPA PLUS ANALYSER
K120056 · DFH
The Binding Site Group , Ltd.
Immunology · 448d
Cleared Mar 27, 2013
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT
K113823 · CFN
The Binding Site Group , Ltd.
Immunology · 456d
Cleared Mar 14, 2013
IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL
K122534 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 206d
Cleared Mar 13, 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN...
K121156 · DHB
Phadia AB
Immunology · 331d
Cleared Feb 26, 2013
QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA
K120817 · MID
Inova Diagnostics, Inc.
Immunology · 344d
Cleared Feb 13, 2013
TRANSFERRIN KIT FOR USE ON THE SPAPLUS
K120236 · DDG
The Binding Site Group , Ltd.
Immunology · 384d
Cleared Jan 29, 2013
IMMUNOCAP ALLERGEN K82
K121463 · DHB
Thermo Fisher Scientific
Immunology · 257d