DHB · Class II · 21 CFR 866.5750

FDA Product Code DHB: System, Test, Radioallergosorbent (rast) Immunological

Leading manufacturers include Pharmacia, Inc., Diagnostic Products Corp. and Incstar Corp..

268
Total
268
Cleared
109d
Avg days
1977
Since
268 devices
25–48 of 268
Cleared Jun 28, 2013
IMMUNOCAP ALLERGEN i3, COMMON WASP VENOM (YELLOW JACKET), AND IMMUNOCAP ALLERGEN i4, PAPER WASP VENOM
K123275
Phadia AB
Immunology · 252d
Cleared Mar 13, 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN SPECIFIC IGE ANTIBODIES
K121156
Phadia AB
Immunology · 331d
Cleared Jan 29, 2013
IMMUNOCAP ALLERGEN K82
K121463
Thermo Fisher Scientific
Immunology · 257d
Cleared Dec 20, 2012
AP 72OS SEMI-AUTOMATED INSTRUMENT
K112910
Hitachi Chemical Diagnostics, Inc.
Immunology · 444d
Cleared Sep 13, 2012
IMMUNOCAP ALLERGEN COMPONENTS BUNDLE
K113841
Phadia US, Inc.
Immunology · 260d
Cleared Jan 06, 2012
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K112523
Siemens Healthcare Diagnostics, Inc.
Immunology · 128d
Cleared Dec 22, 2011
IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS
K111919
Phadia US, Inc.
Immunology · 168d
Cleared Aug 01, 2011
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K101572
Siemens Healthcare Diagnostics
Immunology · 423d
Cleared May 27, 2011
IMMUNOCAP ALLERGEN D202, ALLERGEN COMPONENT NDER P 1, HOUSE DUST MITE, IMMUNOCAP ALLERGEN D203, ALLERGEN
K101251
Phadia AB
Immunology · 388d
Cleared Mar 28, 2011
IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6
K093987
Siemens Healthcare Diagnostics, Inc.
Immunology · 459d
Cleared Dec 15, 2010
IMMUNOCAP ALLERGEN F20, ALMOND MODEL: 14-4179-01
K100999
Phadia AB
Immunology · 247d
Cleared Sep 30, 2010
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K093107
Siemens Healthcare Diagnostics
Immunology · 364d
Cleared Jan 19, 2010
IMMUNOCAP RAPID READER, MODEL 12-3600-10
K092978
Phadia US, Inc.
Immunology · 113d
Cleared Nov 20, 2009
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01
K092050
Phadia AB
Immunology · 136d
Cleared Aug 06, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K091289
Siemens Healthcare Diagnostics
Immunology · 97d
Cleared May 26, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K090257
Siemens Healthcare Diagnostics
Immunology · 113d
Cleared Mar 24, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083853
Siemens Healthcare Diagnostics
Immunology · 90d
Cleared Mar 16, 2009
IMMUNOCAP RAPID INHALANT PROFILE , IMMUNOCAP RAPID READER, IMMUNOCAP RAPID READER CHECK DEVICE, AND IMMUNOCAP RAPID QC1
K081830
Phadia AB
Immunology · 259d
Cleared Mar 11, 2009
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT
K083314
Siemens Healthcare Diagnostics
Immunology · 121d
Cleared May 22, 2008
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
K081217
Hycor Biomedical, Inc.
Immunology · 22d
Cleared Mar 05, 2008
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
K080322
Hycor Biomedical, Inc.
Immunology · 28d
Cleared Aug 24, 2007
IMMUNOCAP ALLERGEN F338, SCALLOP WITH MODEL(S): 14-4895-01
K071913
Phadia AB
Immunology · 44d
Cleared Jan 23, 2006
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY
K051677
Hitachi Chemical Diagnostics, Inc.
Immunology · 216d
Cleared Jun 09, 2005
MODIFICATION TO: UNICAP SPECIFIC IGE
K051218
Pharmacia Diagnostics AB
Immunology · 28d