Company ยท US
Hemagen Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2004. Name variants (Inc, Corp, punctuation) are merged.
52510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 16 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 |
| MID | System, Test, Anticardiolipin Immunological | 3 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 3 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 |
| CFR | Hexokinase, Glucose | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CJY | Azo Dye, Calcium | 1 |
| DBM | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| DDS | Prealbumin, Fitc, Antigen, Antiserum, Control | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
| LBR | Ldl & Vldl Precipitation, Hdl | 1 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 30, 2004 | K041052 | RAICHEM GLUCOSE UV (LIQUID) Hemagen Diagnostics, Inc. | CFR |
| Jun 30, 2004 | K041051 | RAICHEM BUN RATE REAGENT (LIQUID) Hemagen Diagnostics, Inc. | CDQ |
| Jun 25, 2004 | K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT Hemagen Diagnostics, Inc. | CIC |
| Jun 16, 2003 | K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 Hemagen Diagnostics, Inc. | JJY |
| Dec 24, 2002 | K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER Hemagen Diagnostics, Inc. | LBR |
| Sep 17, 2002 | K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT Hemagen Diagnostics, Inc. | MRR |
| Sep 3, 2002 | K022767 | RAICHEM LIPID CALIBRATOR Hemagen Diagnostics, Inc. | JIX |
| Jul 29, 2002 | K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM Hemagen Diagnostics, Inc. | DCK |
| Jul 19, 2002 | K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT Hemagen Diagnostics, Inc. | CJY |
| Oct 15, 2001 | K012668 | RAICHEM GLUCOSE UV REAGENT Hemagen Diagnostics, Inc. | CFR |
| Oct 15, 2001 | K012649 | RAICHEM BUN RATE REAGENT Hemagen Diagnostics, Inc. | CDQ |
| Sep 24, 2001 | K012250 | RAICHEM MULTI-ANALYTE CALIBRATOR Hemagen Diagnostics, Inc. | JIX |
| May 21, 2001 | K010864 | ANALYST PANELS + ANALYTICAL TEST ROTOR Hemagen Diagnostics, Inc. | KHS |
| May 2, 2001 | K011126 | RAICHEM CREATININE URINE STANDARD Hemagen Diagnostics, Inc. | JIT |
| Oct 25, 2000 | K003012 | RAICHEM PHOSPORUS REAGENT Hemagen Diagnostics, Inc. | CEO |
| Aug 30, 1999 | K992243 | VIRGO BETA 2 GLYCOPROTEIN IGM ANTIBODY KIT Hemagen Diagnostics, Inc. | MSV |
| Aug 30, 1999 | K992241 | VIRGO B2 GLYCOPROTEIN I IGA ANTIBODY KIT Hemagen Diagnostics, Inc. | MSV |
| Aug 30, 1999 | K992224 | VIRGO BETA 2 GLYCOPROTEIN IGG ANTIBODY KIT Hemagen Diagnostics, Inc. | MSV |
| Nov 13, 1997 | K973824 | VIRGO PANCO KIT Hemagen Diagnostics, Inc. | MOB |
| Nov 13, 1997 | K973823 | PR 3 ANTIBODY KIT Hemagen Diagnostics, Inc. | MOB |
| Nov 13, 1997 | K973822 | VIRGO ANCA SCREEN KIT Hemagen Diagnostics, Inc. | MOB |
| Aug 28, 1997 | K972812 | RAICHEM PREALBUMIN SPIA Hemagen Diagnostics, Inc. | DDS |
| Jun 20, 1997 | K971909 | VIRGO AMA ELISA KIT Hemagen Diagnostics, Inc. | DBM |
| Jun 3, 1997 | K971039 | HEMAGEN ANTI CARDIOLIPIN SCREEN Hemagen Diagnostics, Inc. | MID |
| Feb 20, 1997 | K944438 | HEMAGEN CMV IGG KIT Hemagen Diagnostics, Inc. | LFZ |
| Dec 5, 1996 | K962276 | HEMAGEN ENA DSDNA KIT (EIA METHOD) Hemagen Diagnostics, Inc. | DHN |
| Sep 12, 1996 | K962836 | HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) Hemagen Diagnostics, Inc. | DHR |
| Mar 12, 1996 | K960324 | HEMAGEN CRP 150 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | DCK |
| Jun 5, 1995 | K952077 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Jun 5, 1995 | K952076 | HEMAGEN ENA SCREENING KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| May 19, 1995 | K930272 | HEMAGEN CHAGAS' KIT (EIA METHOD) Hemagen Diagnostics, Inc. | MIU |
| Mar 29, 1995 | K950414 | HEMAGEN ENA SM/RMP KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946124 | HEMAGEN ENA JO-1 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946123 | HEMAGEN ENA SM KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946122 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946121 | HEMAGEN ENA SS-A KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Feb 22, 1995 | K946120 | HEMAGEN ENA SS-B KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Oct 3, 1994 | K944288 | HEMAGEN C-REACTIVE PROTEIN KIT (EIA METHOD) Hemagen Diagnostics, Inc. | DCK |
| Jun 30, 1994 | K941840 | HEMAGEN ACL IGA CALIBRATOR Hemagen Diagnostics, Inc. | MID |
| Apr 20, 1994 | K935828 | HEMAGEN ENA SCREEN-6 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Jul 16, 1993 | K932373 | HEMAGEN CARDIOLIPIN ANTIBODY KIT (EIA METHOD0 Hemagen Diagnostics, Inc. | MID |
| Apr 7, 1992 | K915420 | HEMAGEN ENA [JO-1] KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Mar 17, 1992 | K915272 | HEMAGEN ENA [RNP/SM] KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LJM |
| Feb 12, 1992 | K915282 | HEMAGEN ENA SCL-70 KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Dec 20, 1991 | K915234 | HEMAGEN ENA (SS-A/SS-B) KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Dec 20, 1991 | K915058 | HEMAGEN ENA SCREENING KIT (EIA METHOD) Hemagen Diagnostics, Inc. | LLL |
| Mar 6, 1991 | K910232 | HEMAGEN ENA SCREENING KIT Hemagen Diagnostics, Inc. | LLL |
| May 18, 1990 | K902139 | HEMAGEN ENA [JO-I] KIT Hemagen Diagnostics, Inc. | DHN |
| Feb 23, 1990 | K900617 | SERATEST ENA [SSA] KIT Hemagen Diagnostics, Inc. | LLL |
| Aug 2, 1989 | K894411 | SERATEST ENA [SCL-70] KIT Hemagen Diagnostics, Inc. | LKJ |
Newest 50 of 52.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||