Hycel, Inc.
Medical device manufacturer in Mchenry, IL.
22510(k) clearances
0PMA approvals
0recalls
Device types
- GKL Counter, Cell, Automated (Particle Counter) 5
- CFH Tetrazolium Int Dye-Diaphorase, Lactate… 2
- CIC Cresolphthalein Complexone, Calcium 1
- JJO Flame Emission Photometer For Clinical Use 1
- JMO Ferrozine (Colorimetric) Iron Binding… 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- GKK Cyanomethemoglobin 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- CDB Porter Silber Hydrazone, 17-Hydroxycorticost… 1
- CDW Diacetyl-Monoxime, Urea Nitrogen 1
- JJE Analyzer, Chemistry (Photometric… 1
- JPJ Red-Cell Indices, Calculated 1
- KNK Acid, Uric, Uricase (Colorimetric) 1
- CCY Zimmerman (Spectrophotometric)… 1
- JJF Analyzer, Chemistry, Micro, For Clinical Use 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K802422 | Hycel Trigyceride II Test · Traditional | 10/06/1980SESP |
| K790335 | Hycel MJJF · Traditional | 02/27/1979SE |
| K782176 | Hycel Ldh-Int TestCFH · Traditional | 01/26/1979SE |
| K782116 | Ketosteroid Test, HYCEL-17CCY · Traditional | 01/26/1979SE |
| K782102 | Hycel Counter 211GKL · Traditional | 01/03/1979SE |
| K782101 | Hycel Counter 222GKL · Traditional | 01/03/1979SE |
| K782100 | Hycel Counter 333GKL · Traditional | 01/03/1979SE |
| K781004 | Hma Uric Acid TestKNK · Traditional | 07/27/1978SE |
| K780946 | Royco Model 970 Hematology Data AnalyzerJPJ · Traditional | 07/27/1978SE |
| K780464 | Lelective Kinetic SYSTEM-60JJE · Traditional | 05/03/1978SE |
| K780262 | Direct Urea Nitrogen TestCDW · Traditional | 04/05/1978SE |
| K772426 | 17-HYDROXY TestCDB · Traditional | 01/30/1978SE |
| K771259 | Albumin Test, Hma Albumin TestCIX · Traditional | 08/22/1977SE |
| K771353 | Platelet Counter & Hematocrit Acces.GKL · Traditional | 08/10/1977SE |
| K771343 | Ldh-Int TestCFH · Traditional | 08/10/1977SE |
| K771154 | Cpk-Int Test · Traditional | 07/21/1977SE |
| K771107 | Counter 700 & HC-700 Hemo 0 Ref.GKL · Traditional | 07/11/1977SE |
| K770803 | Hemotology Produ&Ts (5 in All)GKK · Traditional | 07/05/1977SE |
| K770643 | Creatinine Test, Super SeventeenCGX · Traditional | 06/24/1977SE |
| K770748 | Test, Ferrozine Iron & Iron BindingJMO · Traditional | 06/01/1977SE |
| K770393 | Propane, High Purity, Instrument GradeJJO · Traditional | 04/26/1977SE |
| K760468 | Test, Reformulated Hycel Hma CalciumCIC · Traditional | 11/01/1976SE |