Hycor Biomedical, Inc. - FDA 510(k) Cleared Devices
Recent clearances: HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM, HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200, AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
51
Total
51
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hycor Biomedical, Inc. Immunology ✕
38 devices
Cleared
May 22, 2008
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM
Immunology
22d
Cleared
Mar 05, 2008
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200
Immunology
28d
Cleared
Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA
Immunology
104d
Cleared
Dec 18, 2002
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA
Immunology
104d
Cleared
May 21, 1997
HYCOR ALLERGEN DISC
Immunology
153d
Cleared
Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
Immunology
249d
Cleared
Mar 07, 1997
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY
Immunology
249d
Cleared
Mar 07, 1997
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY
Immunology
249d
Cleared
Mar 07, 1997
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY
Immunology
249d
Cleared
Mar 07, 1997
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY
Immunology
249d
Cleared
Mar 07, 1997
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY
Immunology
249d
Cleared
Mar 07, 1997
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY
Immunology
249d
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