Hemagen Diagnostics, Inc.: FDA clearances and approvals
Hemagen Diagnostics, Inc. has 52 FDA 510(k) clearances (first 1986, latest 2004), across 24 product codes in 3 review panels. Median 510(k) review time: 60 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 16 | 16 |
| DCK | C-Reactive Protein, Antigen, Antiserum, And Control | 3 | 3 |
| MID | System, Test, Anticardiolipin Immunological | 3 | 3 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 3 | 3 |
| MSV | System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi) | 3 | 3 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 2 | 2 |
| CFR | Hexokinase, Glucose | 2 | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 2 | 2 |
| DHR | System, Test, Rheumatoid Factor | 2 | 2 |
| JIX | Calibrator, Multi-Analyte Mixture | 2 | 2 |
Plus 14 more product codes.
Review panels
- Immunology (36)
- Clinical Chemistry (14)
- Microbiology (2)
Most recent Hemagen Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K041052 | RAICHEM GLUCOSE UV (LIQUID) | CFR | 2004-06-30 | 72 |
| K041051 | RAICHEM BUN RATE REAGENT (LIQUID) | CDQ | 2004-06-30 | 72 |
| K041009 | RAICHEM CALCIUM (OCPC) LIQUID REAGENT | CIC | 2004-06-25 | 67 |
| K031101 | RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2 | JJY | 2003-06-16 | 70 |
| K023784 | RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER | LBR | 2002-12-24 | 42 |
| K022772 | RAICHEM LDL-CHOLESTEROL DIRECT REAGENT | MRR | 2002-09-17 | 27 |
| K022767 | RAICHEM LIPID CALIBRATOR | JIX | 2002-09-03 | 13 |
| K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM | DCK | 2002-07-29 | 105 |
| K022049 | MODIFICATION TO RAICHEM CALCIUM REAGENT | CJY | 2002-07-19 | 25 |
| K012668 | RAICHEM GLUCOSE UV REAGENT | CFR | 2001-10-15 | 63 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Hemagen Diagnostics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Hemagen Diagnostics, Inc. have?
Hemagen Diagnostics, Inc. has 52 FDA 510(k) clearances (first 1986, latest 2004), across 24 product codes in 3 review panels.
How long does FDA take to clear Hemagen Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Hemagen Diagnostics, Inc.'s cleared 510(k)s is 60 days.
What devices does Hemagen Diagnostics, Inc. make?
Its most frequent FDA product codes are LLL (Extractable Antinuclear Antibody, Antigen And Control, 16); DCK (C-Reactive Protein, Antigen, Antiserum, And Control, 3); MID (System, Test, Anticardiolipin Immunological, 3).
Has Hemagen Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Hemagen Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 52 Hemagen Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Hemagen Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.