FDA.reportPublic FDA data

HYCOR BIOMEDICAL

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
20164731000125787HYCOR BIOMEDICAL1N2026-01-017272 Chapman Ave GARDEN GROVE CA US 92841

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
339431478632554K994338AUTOSTAT II RHEUMATOID FACTOR IGM ELISADHR2000-02-03
339431403202362K993557AUTOSTAT II RHEUMATOID FACTOR IGA ELISADHR2000-03-03
339431482803648K993304AUTOSTAT II RHEUMATOID FACTOR IGG ELISADHR1999-12-06
339431070310997K993087AUTOSTAT II ANTI-GLIADIN IGG ELISAMST1999-11-12
339432005673884K993086AUTOSTAT II ANTI-GLIADIN IGA ELISAMST1999-11-12
339431816013818K993085AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISAMID2000-02-01
339431130699085K992449AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISAMID1999-11-24
339431116842007K992440AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISAMID1999-09-21
339431030261131K991942AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISAMLE1999-08-24
339431792253933K991890AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISAMVJ1999-08-09
339431068488397K990798AUTOSTAT II ANTI-JO-1 ELISALLL1999-04-28
339431297894683K990797AUTOSTAT II ANTI-SCL-70 ELISALLL1999-04-28
339431875083841K990796AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISAMOB1999-04-28
339431313611950K990627AUTOSTAT II ANTI-SS-A/RO ELISALLL1999-04-28
339431048814752K990626AUTOSTAT II ANTI-SS-B/LA ELISALLL1999-04-28
339431113320133K990625AUTOSTAT II ANTI-SM ELISALKP1999-04-28
339431226631937K990624AUTOSTAT II ANTI-SM/RNP ELISALKO1999-04-28
339431794630059K983921AUTOSTAT II ENA SCREEN ELISALLL1998-12-28
339431694251295K983655AUTOSTAT II ANA SCREEN ELISALJM1999-01-28
339431539390491K965094HYCOR ALLERGEN DISCDHB1997-05-21
339431017495662K952567AUTOSTATTMII ANTI-DSDNALRM1997-03-04
339431285890651K943625AUTOSTAT II ANTI-THYROGLOBULINDDC1994-12-22
339431885218262K943580AUTOSTAT II ANTI-TPOJNL1995-04-17
339431087976625K941278HY-TEC AUTOMATED EIA SYSTEMDHB1995-03-13
339431336935423K925044VENTREX ALLERGEN DISCDHB1993-05-14
339431379349113K913833VENTREX ALLERGEN DISCDHB1992-02-21
339431280276047K841651VAST VENTREX RAST ALLDGC1984-06-01
339431724933032K831554NEIN ALLERGEN DISC IN VAST VENTREX TESTDHB1983-06-08
339431757719734K831091NEW ALLERGEN DISC -VAST VENTEX ALLERGYDHB1983-04-27
339431985941097K830817NEW ALLERGEN DISCS FOR USE IN VAST VENTDGC1983-04-27
339431644146884K822442VAST VENTREX RAST ALLERGEN DISCSDGC1982-09-02
339431303949121K821451VAST VENTREX ALLERGY SYSTEMS TESTSDHB1982-06-23
339431896965245K261027NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellana); Capture Reagent F352, Ara h 8 PR-10, Peanut; Capture Reagent F423, Ara h 2, Peanut; Capture Reagent F447, Ara h 6, PeanutDHB2026-07-24
339431019395140K260591NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus communis);Capture Reagent F078, Bos d 8 Casein, Milk; Capture Reagent F080, Lobster (Homarus gammarus);Capture Reagent F422, Ara h 1, PeanutDHB2026-07-21
339431237003276K260280NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp.); Capture Reagent F079, Gluten, Wheat; Capture Reagent F202, Cashew Nut (Anacardium occidentale); Capture Reagent F233, Gal d 1 Ovomucoid EggDHB2026-06-18
339431943358932K260059NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Cocos nucifera); Capture Reagent F040, Tuna (Thunnus sp.); Capture Reagent F041, Salmon (Salmo salar); Capture Reagent F075, Egg Yolk (Gallus gallus); Capture Reagent F201, Pecan Nut (Carya illinoensis); Capture Reagent F203, Pistachio Nut (Pistacia vera); Capture Reagent F290, Oyster (Ostrea edulis)DHB2026-05-15
339431235604849K252775NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin, Milk; Capture Reagent F077, Bos d 5 ß-lactoglobulin, Milk; Capture Reagent F232, Gal d 2 Ovalbumin, EggDHB2026-01-16
339431677425419K252493NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenaria); Capture Reagent F256, Walnut (Juglans spp.) ; Capture Reagent I006, German Cockroach (Blatella germanica)DHB2025-12-23
339431782998032K242531NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Quercus alba) ; Capture Reagent G002, Bermuda Grass (Cynodon dactylon); Capture Reagent W001, Common Ragweed (Ambrosia artemisiifolia); Capture Reagent E005, Dog Dander (Canis familiaris); Capture Reagent T003, Common Silver Birch (Betula verrucosa); Capture Reagent F001, Egg White (Gallus gallus); Capture Reagent F002, Cow's Milk (Bos taurus); NOVEOS Immunoassay AnalyzDHB2025-04-23
339431358768075K220162Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, AlternariaDHB2022-02-18
339431556213418K200825NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Reagent Timothy Grass- G006, Phleum pratenseDHB2020-06-26
339431214727158K191510Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinaeDHB2019-07-31
339431974238463K182479NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinusDHB2018-12-04
339431903487539K043433AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISAMVM2005-03-07
339431511069173K033744AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISAMVM2004-01-20
339431421221057K030741AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISAMID2003-05-01
339431187524253K030397AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISAMSV2003-03-21
339431080315336K022945AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISAMSV2002-12-18
339431995176831K022944AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISAMSV2002-12-18
339431702713572K003054AUTOSTAT II ENA-6 PROFILE ELISALLL2000-10-13
339431112795526K002215AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISAMOB2000-09-28
339431000274683
339431142895846
339431385605742
339431412360474
339431495652714
339431649815883
339431726468962
339431876788688
339431912440695
339431985914128

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DHB202026-07-24
LLL62000-10-13
MID42003-05-01
MSV32003-03-21
DHR32000-03-03
DGC31984-06-01
MVM22005-03-07
MOB22000-09-28
MST21999-11-12
MLE11999-08-24
MVJ11999-08-09
LKP11999-04-28
LKO11999-04-28
LJM11999-01-28
LRM11997-03-04
JNL11995-04-17
DDC11994-12-22

PMN#