Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Hemagen Diagnostics, Inc. · Predicate Candidate Screening
52 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
60 daysmedian FDA review time
113 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | Hemagen Diagnostics, Inc. | 2004-06-30 | 72 | 0 |
| K041052 | RAICHEM GLUCOSE UV (LIQUID) | Hemagen Diagnostics, Inc. | 2004-06-30 | 72 | 0 |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | Hemagen Diagnostics, Inc. | 2004-06-25 | 67 | 1 |
| K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 | Hemagen Diagnostics, Inc. | 2003-06-16 | 70 | 0 |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBE | Hemagen Diagnostics, Inc. | 2002-12-24 | 42 | 0 |
| K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | Hemagen Diagnostics, Inc. | 2002-09-17 | 27 | 0 |
| K022767 | RAICHEM LIPID CALIBRATOR | Hemagen Diagnostics, Inc. | 2002-09-03 | 13 | 0 |
| K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM | Hemagen Diagnostics, Inc. | 2002-07-29 | 105 | 0 |
| K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | Hemagen Diagnostics, Inc. | 2002-07-19 | 25 | 0 |
| K012668 | RAICHEM GLUCOSE UV REAGENT | Hemagen Diagnostics, Inc. | 2001-10-15 | 63 | 0 |
| K012649 | RAICHEM BUN RATE REAGENT | Hemagen Diagnostics, Inc. | 2001-10-15 | 63 | 0 |
| K012250 | RAICHEM MULTI-ANALYTE CALIBRATOR | Hemagen Diagnostics, Inc. | 2001-09-24 | 69 | 0 |
| K010864 | ANALYST PANELS + ANALYTICAL TEST ROTOR | Hemagen Diagnostics, Inc. | 2001-05-21 | 60 | 0 |
| K011126 | RAICHEM CREATININE URINE STANDARD | Hemagen Diagnostics, Inc. | 2001-05-02 | 19 | 0 |
| K003012 | RAICHEM PHOSPORUS REAGENT | Hemagen Diagnostics, Inc. | 2000-10-25 | 29 | 0 |
| K992241 | VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | 60 | 0 |
| K992224 | VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | 60 | 0 |
| K992243 | VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1999-08-30 | 60 | 0 |
| K973824 | VIRGO PANCO KIT | Hemagen Diagnostics, Inc. | 1997-11-13 | 37 | 0 |
| K973823 | PR 3 ANTIBODY KIT | Hemagen Diagnostics, Inc. | 1997-11-13 | 37 | 0 |
| K973822 | VIRGO ANCA SCREEN KIT | Hemagen Diagnostics, Inc. | 1997-11-13 | 37 | 0 |
| K972812 | RAICHEM PREALBUMIN SPIA | Hemagen Diagnostics, Inc. | 1997-08-28 | 31 | 0 |
| K971909 | VIRGO AMA ELISA KIT | Hemagen Diagnostics, Inc. | 1997-06-20 | 28 | 0 |
| K971039 | HEMAGEN ANTI CARDIOLIPIN SCREEN | Hemagen Diagnostics, Inc. | 1997-06-03 | 74 | 0 |
| K944438 | HEMAGEN CMV IGG KIT | Hemagen Diagnostics, Inc. | 1997-02-20 | 892 | 0 |
| K962276 | HEMAGEN ENA DSDNA KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1996-12-05 | 175 | 0 |
| K962836 | HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1996-09-12 | 52 | 0 |
| K960324 | HEMAGEN CRP 150 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1996-03-12 | 49 | 0 |
| K952077 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-06-05 | 33 | 0 |
| K952076 | HEMAGEN ENA SCREENING KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-06-05 | 33 | 0 |
| K930272 | HEMAGEN CHAGAS' KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-05-19 | 850 | 0 |
| K950414 | HEMAGEN ENA SM/RMP KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-03-29 | 57 | 0 |
| K946121 | HEMAGEN ENA SS-A KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | 69 | 0 |
| K946120 | HEMAGEN ENA SS-B KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | 69 | 0 |
| K946124 | HEMAGEN ENA JO-1 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | 69 | 0 |
| K946123 | HEMAGEN ENA SM KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | 69 | 0 |
| K946122 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1995-02-22 | 69 | 0 |
| K944288 | HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1994-10-03 | 31 | 0 |
| K941840 | HEMAGEN ACL IGA CALIBRATOR | Hemagen Diagnostics, Inc. | 1994-06-30 | 78 | 0 |
| K935828 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1994-04-20 | 134 | 0 |
| K932373 | HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 | Hemagen Diagnostics, Inc. | 1993-07-16 | 60 | 0 |
| K915420 | HEMAGEN ENA [JO-1] KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1992-04-07 | 127 | 0 |
| K915272 | HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1992-03-17 | 113 | 0 |
| K915282 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1992-02-12 | 79 | 0 |
| K915234 | HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1991-12-20 | 28 | 0 |
| K915058 | HEMAGEN ENA SCREENING KIT (EIA METHOD) | Hemagen Diagnostics, Inc. | 1991-12-20 | 42 | 0 |
| K910232 | HEMAGEN ENA SCREENING KIT | Hemagen Diagnostics, Inc. | 1991-03-06 | 47 | 0 |
| K902139 | HEMAGEN ENA [JO-I] KIT | Hemagen Diagnostics, Inc. | 1990-05-18 | 9 | 0 |
| K900617 | SERATEST ENA [SSA] KIT | Hemagen Diagnostics, Inc. | 1990-02-23 | 15 | 0 |
| K894411 | SERATEST ENA [SCL-70] KIT | Hemagen Diagnostics, Inc. | 1989-08-02 | 16 | 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