Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hycor Biomedical, Inc. — Predicate Candidate Screening
51 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
123 daysmedian FDA review time
249 days90th percentile
51clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081217 | HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM | Hycor Biomedical, Inc. | 2008-05-22 | 22 | 0 |
| K080322 | HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREE | Hycor Biomedical, Inc. | 2008-03-05 | 28 | 0 |
| K022945 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISA | Hycor Biomedical, Inc. | 2002-12-18 | 104 | 0 |
| K022944 | AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISA | Hycor Biomedical, Inc. | 2002-12-18 | 104 | 0 |
| K965094 | HYCOR ALLERGEN DISC | Hycor Biomedical, Inc. | 1997-05-21 | 153 | 0 |
| K962730 | HYCOR HY.TEC/MANUAL DS-DNA AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962578 | HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962727 | HYCOR HY.TEC/MANUAL RNP AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962720 | HYCOR HY.TEC/MANUAL SCL-70 AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962731 | HYCOR HY.TEC/MANUAL JO-1 AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962719 | HYCOR HY.TEC/MANUAL SS-A AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962729 | HYCOR HY.TEC/MANUAL RF AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962722 | HYCOR HY.TEC/MANUAL SM AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962728 | HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY | Hycor Biomedical, Inc. | 1997-03-07 | 249 | 0 |
| K962451 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) | Hycor Biomedical, Inc. | 1996-11-25 | 160 | 0 |
| K962341 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) | Hycor Biomedical, Inc. | 1996-11-25 | 160 | 0 |
| K962450 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE | Hycor Biomedical, Inc. | 1996-11-25 | 160 | 0 |
| K962452 | HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA | Hycor Biomedical, Inc. | 1996-11-25 | 160 | 0 |
| K954897 | HYTEC AUTOIMMUNE KITS (RNP) | Hycor Biomedical, Inc. | 1996-03-22 | 185 | 0 |
| K954896 | HYTEC AUTOIMMUNE KITS (SM) | Hycor Biomedical, Inc. | 1996-03-22 | 185 | 0 |
| K954894 | HYTEC AUTOIMMUNE KITS (SCL-70) | Hycor Biomedical, Inc. | 1996-03-20 | 183 | 0 |
| K954895 | HYTEC AUTOIMMUNE KIT (JO-1) | Hycor Biomedical, Inc. | 1996-03-20 | 147 | 0 |
| K954893 | HYTEC AUTOMIMMUNE KIT (DS-DNA) | Hycor Biomedical, Inc. | 1996-03-20 | 147 | 0 |
| K954392 | HYTEC AUTOIMMUNE KIT (SS-A) | Hycor Biomedical, Inc. | 1995-12-26 | 98 | 0 |
| K954891 | HYTEC AUTOIMMUNE KITS (SS-B) | Hycor Biomedical, Inc. | 1995-12-26 | 98 | 0 |
| K954890 | HYTEC AUTOMMUNE KIT (ENA) | Hycor Biomedical, Inc. | 1995-12-26 | 62 | 0 |
| K954892 | HYTEC AUTOMIMMUNE KIT (RF) | Hycor Biomedical, Inc. | 1995-12-26 | 62 | 0 |
| K945884 | SPECIFIC IGE ULTRA-EIA | Hycor Biomedical, Inc. | 1995-06-30 | 211 | 0 |
| K945748 | HYCOR SPECIFIC IGE ENZYME IMMUNOASSAY | Hycor Biomedical, Inc. | 1995-06-07 | 196 | 0 |
| K941278 | HY-TEC AUTOMATED EIA SYSTEM | Hycor Biomedical, Inc. | 1995-03-13 | 361 | 0 |
| K941057 | SPECIFIC IGE EIA-ULTRA ASSAY | Hycor Biomedical, Inc. | 1995-01-20 | 318 | 0 |
| K942853 | KOVA LIQUA-TROL | Hycor Biomedical, Inc. | 1994-10-04 | 110 | 0 |
| K940183 | HY-TEC TOTAL IGE ENZYME IMMUNOASSAY | Hycor Biomedical, Inc. | 1994-05-17 | 125 | 0 |
| K925425 | SPECIFIC IGE EIA-TURBO ASSAY | Hycor Biomedical, Inc. | 1993-01-14 | 79 | 0 |
| K924044 | VENTREX ALLERGEN DISC | Hycor Biomedical, Inc. | 1992-12-01 | 112 | 0 |
| K924209 | VENTREX ALLERGEN DISC | Hycor Biomedical, Inc. | 1992-11-30 | 102 | 0 |
| K923284 | BASELINE CALIBRATION VERIFICATION CONTROLS | Hycor Biomedical, Inc. | 1992-09-28 | 84 | 0 |
| K923445 | PYLORAGEN HELICBACTER PYLORI TEST KIT - MODIFIED | Hycor Biomedical, Inc. | 1992-09-11 | 65 | 0 |
| K921574 | WHITE ASH - FRAXINUS AMERICANA (T15) ALLERGEN DISC | Hycor Biomedical, Inc. | 1992-08-03 | 123 | 0 |
| K922538 | VENTREX ALLERGEN DISC | Hycor Biomedical, Inc. | 1992-07-27 | 59 | 0 |
| K920856 | VENTREX COATED TUBE HIGH SENSIT. TSH RADIOIMMUNOAS | Hycor Biomedical, Inc. | 1992-03-26 | 37 | 0 |
| K912255 | HYCOR PYLORAGEN HELICOBACTER PYLORI TEST | Hycor Biomedical, Inc. | 1991-10-11 | 142 | 0 |
| K904115 | HYCOR ACCUPINCH METHAMPHETAMINE TEST | Hycor Biomedical, Inc. | 1990-11-28 | 83 | 0 |
| K901334 | HYCOR ACCUPINCH THC TEST | Hycor Biomedical, Inc. | 1990-05-14 | 53 | 0 |
| K900921 | HYCOR ACCUPINCH PHENCYCLIDINE TEST | Hycor Biomedical, Inc. | 1990-04-26 | 58 | 0 |
| K900173 | HYCOR ACCUPINCH MORPHINE TEST | Hycor Biomedical, Inc. | 1990-03-30 | 77 | 0 |
| K896937 | HYCOR ACCUPINCH COCAINE TEST | Hycor Biomedical, Inc. | 1990-03-06 | 83 | 0 |
| K894934 | HYCOR SENTRY DRUGS OF ABUSE URINE CALIBRATORS | Hycor Biomedical, Inc. | 1989-10-17 | 75 | 0 |
| K893815 | HYCOR SENTRY(TM) DRUGS OF ABUSE URINE CALIBRATORS | Hycor Biomedical, Inc. | 1989-07-25 | 63 | 0 |
| K892332 | DRUGS OF ABUSE URINE CALIBRATORS | Hycor Biomedical, Inc. | 1989-05-11 | 36 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda