Medical Device Manufacturer · US , Garden Grove , CA

Hycor Biomedical, Inc.

51 submissions · 51 cleared · Since 1989
51
Total
51
Cleared
0
Denied

Hycor Biomedical, Inc. — FDA 510(k) Submissions

Hycor Biomedical, Inc. has submitted 51 FDA 510(k) premarket notifications since 1989, of which 51 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Test, Radioallergosorbent (rast) Immunological, Extractable Antinuclear Antibody, Antigen And Control, Calibrators, Drug Mixture, Antinuclear Antibody, Antigen, Control, System, Test, Rheumatoid Factor . Use the specialty filter in the sidebar to narrow results.

51 devices
1–25 of 51
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
K081217 · DHB System, Test,... · Immunology
May 2008 22d
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
K080322 · DHB System, Test,... · Immunology
Mar 2008 28d
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
K022944 · MSV System,test,antibodies,b2... · Immunology
Dec 2002 104d
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
K022945 · MSV System,test,antibodies,b2... · Immunology
Dec 2002 104d
HYCOR ALLERGEN DISC
K965094 · DHB System, Test,... · Immunology
May 1997 153d
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
K962578 · LLL Extractable Antinuclear... · Immunology
Mar 1997 249d
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
K962719 · LLL Extractable Antinuclear... · Immunology
Mar 1997 249d
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
K962720 · LLL Extractable Antinuclear... · Immunology
Mar 1997 249d
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
K962722 · LLL Extractable Antinuclear... · Immunology
Mar 1997 249d
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
K962727 · LLL Extractable Antinuclear... · Immunology
Mar 1997 249d
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
K962728 · LLL Extractable Antinuclear... · Immunology
Mar 1997 249d
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
K962729 · DHR System, Test, Rheumatoid... · Immunology
Mar 1997 249d
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY
K962730 · LRM Anti-dna Antibody... · Immunology
Mar 1997 249d
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY
K962731 · LLL Extractable Antinuclear... · Immunology
Mar 1997 249d
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG)
K962341 · JNL Immunochemical,... · Immunology
Nov 1996 160d
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE
K962450 · LJM Antinuclear Antibody... · Immunology
Nov 1996 160d
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO)
K962451 · JNL Immunochemical,... · Immunology
Nov 1996 160d
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA
K962452 · DBM Antimitochondrial... · Immunology
Nov 1996 160d
HYTEC AUTOIMMUNE KITS (SM)
K954896 · LKP Anti-sm Antibody, Antigen... · Immunology
Mar 1996 185d
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · LKO Anti-rnp Antibody,... · Immunology
Mar 1996 185d
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · LRM Anti-dna Antibody... · Immunology
Mar 1996 147d
HYTEC AUTOIMMUNE KITS (SCL-70)
K954894 · LLL Extractable Antinuclear... · Immunology
Mar 1996 183d
HYTEC AUTOIMMUNE KIT (JO-1)
K954895 · LLL Extractable Antinuclear... · Immunology
Mar 1996 147d
HYTEC AUTOIMMUNE KIT (SS-A)
K954392 · LKJ Antinuclear Antibody,... · Immunology
Dec 1995 98d
HYTEC AUTOMMUNE KIT (ENA)
K954890 · LLL Extractable Antinuclear... · Immunology
Dec 1995 62d
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