Company ยท US
Hycor Biomedical, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1989 to 2026. Name variants (Inc, Corp, punctuation) are merged.
66510(k) clearances (6 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 25 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 10 |
| DHR | System, Test, Rheumatoid Factor | 4 |
| DKB | Calibrators, Drug Mixture | 3 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 3 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 2 |
| LKJ | Antinuclear Antibody, Antigen, Control | 2 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 2 |
| LYR | Helicobacter Pylori | 2 |
| MVM | Autoantibodies, Endomysial(Tissue Transglutaminase) | 2 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 |
| DIF | Drug Mixture Control Materials | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 24, 2026 | K261027 | NOVEOS Specific IgE (sIgE); Capture Reagent F014, Soybean (Glycine max); Capture Reagent F017, Hazelnut (Corylus avellan Hycor Biomedical | DHB |
| Jul 21, 2026 | K260591 | NOVEOS Specific IgE (sIgE);Capture Reagent F010, Sesame Seed (Sesamum indicum);Capture Reagent F020, Almond (Amygdalus c Hycor Biomedical | DHB |
| Jun 18, 2026 | K260280 | NOVEOS Specific IgE (sIgE); Capture Reagent F004, Wheat (Triticum aestivum); Capture Reagent F023, Crab (Callinectes spp Hycor Biomedical | DHB |
| May 15, 2026 | K260059 | NOVEOS Specific IgE (sIgE); Capture Reagent F018, Brazil Nut (Bertholletia excelsa); Capture Reagent F036, Coconut (Coco Hycor Biomedical | DHB |
| Jan 16, 2026 | K252775 | NOVEOS Specific IgE (sIgE): Capture Reagent F013, Peanut (Arachis hypogaea); Capture Reagent F076, Bos d 4 a-lactalbumin Hycor Biomedical | DHB |
| Dec 23, 2025 | K252493 | NOVEOS Specific IgE (sIgE); Capture Reagent F024, Shrimp (Shrimp spp.); Capture Reagent F207, Clam (Mercenaria mercenari Hycor Biomedical | DHB |
| Apr 23, 2025 | K242531 | NOVEOS Specific IgE (sIgE) Assay; Capture Reagent G010, Johnson Grass (Sorghum halepense); Capture Reagent T007, Oak (Qu Hycor Biomedical | DHB |
| Feb 18, 2022 | K220162 | Noveos Immunoanalyzer System, Noveos Specific IgE (sIgE), Capture Reagent M006, Alternaria Hycor Biomedical | DHB |
| Jun 26, 2020 | K200825 | NOVEOS Specific IgE (sIgE), Capture Reagent Cat Dander - E001, Felis Domesticus; NOVEOS Specific IgE (sIgE), Capture Rea Hycor Biomedical | DHB |
| Jul 31, 2019 | K191510 | Noveos Immunoanalyzer System, Noveos Specific IgE (slgE), Capture Reagent D002, Dermatophagoides farinae Hycor Biomedical | DHB |
| Dec 4, 2018 | K182479 | NOVEOS Immunoassay Analyzer, NOVEOS Specific IgE (sIgE) Assay, Capture Reagent D001, Dermatophagoides pteronyssinus Hycor Biomedical | DHB |
| May 22, 2008 | K081217 | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM Hycor Biomedical, Inc. | DHB |
| Mar 5, 2008 | K080322 | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 Hycor Biomedical, Inc. | DHB |
| Mar 7, 2005 | K043433 | AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA Hycor Biomedical , Ltd., GB | MVM |
| Jan 20, 2004 | K033744 | AUTOSTAT II ANTI-TISUE TRANSGLUTAMINASE IGA ELISA Hycor Biomedical , Ltd., GB | MVM |
| May 1, 2003 | K030741 | AUTOSTAT II ANTI-CARDIOLIPIN IGA ELISA Hycor Biomedical , Ltd., GB | MID |
| Mar 21, 2003 | K030397 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGA ELISA Hycor Biomedical , Ltd., GB | MSV |
| Dec 18, 2002 | K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA Hycor Biomedical, Inc. | MSV |
| Dec 18, 2002 | K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA Hycor Biomedical, Inc. | MSV |
| May 21, 1997 | K965094 | HYCOR ALLERGEN DISC Hycor Biomedical, Inc. | DHB |
| Mar 7, 1997 | K962731 | HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY Hycor Biomedical, Inc. | LRM |
| Mar 7, 1997 | K962729 | HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY Hycor Biomedical, Inc. | DHR |
| Mar 7, 1997 | K962728 | HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962727 | HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962722 | HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962720 | HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962719 | HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Mar 7, 1997 | K962578 | HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY Hycor Biomedical, Inc. | LLL |
| Nov 25, 1996 | K962452 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA Hycor Biomedical, Inc. | DBM |
| Nov 25, 1996 | K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) Hycor Biomedical, Inc. | JNL |
| Nov 25, 1996 | K962450 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE Hycor Biomedical, Inc. | LJM |
| Nov 25, 1996 | K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) Hycor Biomedical, Inc. | JNL |
| Mar 22, 1996 | K954897 | HYTEC AUTOIMMUNE KITS (RNP) Hycor Biomedical, Inc. | LKO |
| Mar 22, 1996 | K954896 | HYTEC AUTOIMMUNE KITS (SM) Hycor Biomedical, Inc. | LKP |
| Mar 20, 1996 | K954895 | HYTEC AUTOIMMUNE KIT (JO-1) Hycor Biomedical, Inc. | LLL |
| Mar 20, 1996 | K954894 | HYTEC AUTOIMMUNE KITS (SCL-70) Hycor Biomedical, Inc. | LLL |
| Mar 20, 1996 | K954893 | HYTEC AUTOMIMMUNE KIT (DS-DNA) Hycor Biomedical, Inc. | LRM |
| Dec 26, 1995 | K954892 | HYTEC AUTOMIMMUNE KIT (RF) Hycor Biomedical, Inc. | DHR |
| Dec 26, 1995 | K954891 | HYTEC AUTOIMMUNE KITS (SS-B) Hycor Biomedical, Inc. | LKJ |
| Dec 26, 1995 | K954890 | HYTEC AUTOMMUNE KIT (ENA) Hycor Biomedical, Inc. | LLL |
| Dec 26, 1995 | K954392 | HYTEC AUTOIMMUNE KIT (SS-A) Hycor Biomedical, Inc. | LKJ |
| Jun 30, 1995 | K945884 | SPECIFIC IGE ULTRA-EIA Hycor Biomedical, Inc. | DHB |
| Jun 7, 1995 | K945748 | HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY Hycor Biomedical, Inc. | DHB |
| Mar 13, 1995 | K941278 | HY-TEC AUTOMATED EIA SYSTEM Hycor Biomedical, Inc. | DHB |
| Jan 20, 1995 | K941057 | SPECIFIC IGE EIA-ULTRA ASSAY Hycor Biomedical, Inc. | DHB |
| Oct 4, 1994 | K942853 | KOVA LIQUA-TROL Hycor Biomedical, Inc. | JJW |
| May 17, 1994 | K940183 | HY-TEC TOTAL IGE ENZYME IMMUNOASSAY Hycor Biomedical, Inc. | DGC |
| Jan 14, 1993 | K925425 | SPECIFIC IGE EIA-TURBO ASSAY Hycor Biomedical, Inc. | DHB |
| Dec 1, 1992 | K924044 | VENTREX ALLERGEN DISC Hycor Biomedical, Inc. | DHB |
Newest 50 of 66.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 25, 2018 | Hycor Biomedical LLC HYTEC Stop Solution (Allergy), 300ml bottle containing 1N sodium hydroxide solution, Part # 308051, sold separately or as a component contained in the following kits: (1) HYTEC Specific/Total IgE EIA Open, Classified |
DHB | K081217 K941278 |
| Mar 19, 2018 | Hycor Biomedical Inc HYTEC 288 System, Model 74007P, automated immunoanalyzer (EIA) instrument. For in vitro diagnostic use only.
HYTEC AUTOSTAT II RF assays: HYTEC AUTOSTAT II RF IgM Kit: Part Number FGA 05, HYTEC AUT Open, Classified |
DHR | K994338 |
| Feb 21, 2018 | Hycor Biomedical Inc AUTOSTAT II IgM Rheumatoid Factor, IVD, Part: FGA 05
Product Usage:
Rheumatoid Factor IgM ELISA is intended to be utilized as either a manual or an automated procedure The Intended Use is as follows: Completed |
DHR | K994338 |