FDA 510(k) Applications Submitted by HYCOR BIOMEDICAL, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K965094 |
12/19/1996 |
HYCOR ALLERGEN DISC |
HYCOR BIOMEDICAL, INC. |
| K962341 |
06/18/1996 |
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) |
HYCOR BIOMEDICAL, INC. |
| K962450 |
06/18/1996 |
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE |
HYCOR BIOMEDICAL, INC. |
| K962451 |
06/18/1996 |
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) |
HYCOR BIOMEDICAL, INC. |
| K962452 |
06/18/1996 |
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA |
HYCOR BIOMEDICAL, INC. |
| K962578 |
07/01/1996 |
HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K962719 |
07/01/1996 |
HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K962720 |
07/01/1996 |
HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K962722 |
07/01/1996 |
HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K962727 |
07/01/1996 |
HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K962728 |
07/01/1996 |
HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K962729 |
07/01/1996 |
HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K962730 |
07/01/1996 |
HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K962731 |
07/01/1996 |
HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY |
HYCOR BIOMEDICAL, INC. |
| K080322 |
02/06/2008 |
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 |
HYCOR BIOMEDICAL, INC. |
| K081217 |
04/30/2008 |
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM |
HYCOR BIOMEDICAL, INC. |
| K022944 |
09/05/2002 |
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA |
HYCOR BIOMEDICAL, INC. |
| K022945 |
09/05/2002 |
AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA |
HYCOR BIOMEDICAL, INC. |
| K954894 |
09/19/1995 |
HYTEC AUTOIMMUNE KITS (SCL-70) |
HYCOR BIOMEDICAL, INC. |
| K954897 |
09/19/1995 |
HYTEC AUTOIMMUNE KITS (RNP) |
HYCOR BIOMEDICAL, INC. |
| K954893 |
10/25/1995 |
HYTEC AUTOMIMMUNE KIT (DS-DNA) |
HYCOR BIOMEDICAL, INC. |
| K954895 |
10/25/1995 |
HYTEC AUTOIMMUNE KIT (JO-1) |
HYCOR BIOMEDICAL, INC. |
| K954896 |
09/19/1995 |
HYTEC AUTOIMMUNE KITS (SM) |
HYCOR BIOMEDICAL, INC. |
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