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
313–336 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Jul 10, 2013
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND...
K131738 · DHB
Phadia AB
Immunology · 27d
Cleared Jul 03, 2013
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
K123256 · DEM
The Binding Site Group , Ltd.
Immunology · 258d
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