Hycor Biomedical, Inc.
Hycor Biomedical, Inc. holds FDA 510(k) medical device clearances, first cleared 1989, most recent 2008, with 2 FDA device recalls on record.
Top product codes for Hycor Biomedical, Inc.
FDA recalls by Hycor Biomedical, Inc.
- Z-2200-2019 — 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 AUTOSTAT II RF IgA Kit: Part Number FGA 06, HYTEC AUTOSTAT II RF IgG Kit: Part Number FGA 07, HYTEC AUTOSTAT II Total Rheumatoid Factor Kit: Part Number FGA 08.
- Z-2134-2019 — 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: Enzyme-linked immunosorbent assay method for the semi-quantitative determination of specific IgM Rheumatoid Factor antibodies in human serum. The results of the IgM RF assay can be used as an aid in the diagnosis of Rheumatoid Arthritis when supported by other laboratory and clinical investigations. Levels of these autoantibodies are one indicator in a multi-factorial diagnostic regime. The assay can be used with the HYCOR HyTec automated EIA instrument. For in vitro diagnostic use only.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Hycor Biomedical, Inc.
- K081217 — HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
- K080322 — HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
- K022944 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
- K022945 — AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
- K965094 — HYCOR ALLERGEN DISC
- K962578 — HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
- K962719 — HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
- K962720 — HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
- K962722 — HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
- K962727 — HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
- K962728 — HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
- K962729 — HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
- K962730 — HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
- K962731 — HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
- K962341 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
- K962450 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
- K962451 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
- K962452 — HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
- K954896 — HYTEC AUTOIMMUNE KITS (SM)
- K954897 — HYTEC AUTOIMMUNE KITS (RNP)
- K954893 — HYTEC AUTOMIMMUNE KIT (DS-DNA)
- K954894 — HYTEC AUTOIMMUNE KITS (SCL-70)
- K954895 — HYTEC AUTOIMMUNE KIT (JO-1)
- K954392 — HYTEC AUTOIMMUNE KIT (SS-A)
- K954890 — HYTEC AUTOMMUNE KIT (ENA)
- K954891 — HYTEC AUTOIMMUNE KITS (SS-B)
- K954892 — HYTEC AUTOMIMMUNE KIT (RF)
- K945884 — SPECIFIC IGE ULTRA-EIA
- K945748 — HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY
- K941278 — HY-TEC AUTOMATED EIA SYSTEM
- K941057 — SPECIFIC IGE EIA-ULTRA ASSAY
- K942853 — KOVA LIQUA-TROL
- K940183 — HY-TEC TOTAL IGE ENZYME IMMUNOASSAY
- K925425 — SPECIFIC IGE EIA-TURBO ASSAY
- K924044 — VENTREX ALLERGEN DISC
- K924209 — VENTREX ALLERGEN DISC
- K923284 — BASELINE CALIBRATION VERIFICATION CONTROLS
- K923445 — PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED
- K921574 — WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC
- K922538 — VENTREX ALLERGEN DISC
- K920856 — VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS
- K912255 — HYCOR PYLORAGEN HELICOBACTER PYLORI TEST
- K904115 — HYCOR ACCUPINCH METHAMPHETAMINE TEST
- K901334 — HYCOR ACCUPINCH THC TEST
- K900921 — HYCOR ACCUPINCH PHENCYCLIDINE TEST
- K900173 — HYCOR ACCUPINCH MORPHINE TEST
- K896937 — HYCOR ACCUPINCH COCAINE TEST
- K894934 — HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS
- K893815 — HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS
- K892332 — DRUGS OF ABUSE URINE CALIBRATORS
- K890957 — HYCOR SENTRY DRUGS OF ABUSE URINE CONTROL:
Data sourced from openFDA. This site is unofficial and independent of the FDA.