Gelman Sciences, Inc.
Medical device manufacturer in Ann Arbor, MI.
32510(k) clearances
0PMA approvals
0recalls
Device types
- JJN Apparatus, Electrophoresis, For Clinical Use 5
- FMF Syringe, Piston 4
- FPB Filter, Infusion Line 3
- JRL Unit, Filter, Membrane 3
- JBD System, Analysis, Electrophoretic Hemoglobin 2
- JJY Multi-Analyte Controls, All Kinds (Assayed) 2
- DTM Filter, Blood, Cardiopulmonary Bypass… 2
- JHO Electrophoretic Separation, Lipoproteins 1
- CZP Iga, Antigen, Antiserum, Control 1
- KRJ Filter, Prebypass, Cardiopulmonary Bypass 1
- JHT Chromatographic Separation, Cpk Isoenzymes 1
- LIB Device, General Purpose, Microbiology… 1
- JQT Densitometer/Scanner (Integrating… 1
- DKB Calibrators, Drug Mixture 1
- DIF Drug Mixture Control Materials 1
- DPA Apparatus, General Use, Thin Layer… 1
- FIB Protector, Transducer, Dialysis 1
- LBT Electrophoresis, Cholesterol Via… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K946190 | Drug Dispensing SpikeFMF · Traditional | 03/17/1995SE |
| K943127 | Pharmassure Large Volume Transfer FiltersFPB · Traditional | 09/29/1994SE |
| K941589 | Syringe Filter DevicesFMF · Traditional | 09/06/1994SE |
| K941020 | Drug Reconstitution Filter DeviceFMF · Traditional | 08/10/1994SE |
| K942275 | Vial Vent FilterFPB · Traditional | 07/26/1994SE |
| K941032 | UnknownFMF · Traditional | 05/27/1994SE |
| K910821 | Transducer ProtectorFIB · Traditional | 08/12/1991SE |
| K892387 | Modified Gelman Arterial FilterDTM · Traditional | 06/22/1989SE |
| K884176 | Chromatography KitDPA · Traditional | 04/04/1989SE |
| K884178 | Drug Control SetDIF · Traditional | 02/17/1989SE |
| K884177 | Drug Standard SetDKB · Traditional | 02/17/1989SE |
| K862068 | Gelman Arterial Filter (43, 33 and 21 Micron)DTM · Traditional | 08/08/1986SE |
| K850260 | Gleman ACD-2020 Automatic Computing DensitometerJQT · Traditional | 02/27/1985SE |
| K850202 | Gelman Triphor ControlJJY · Traditional | 02/06/1985SE |
| K842052 | Giardia GuardLIB · Traditional | 09/11/1984SE |
| K842560 | OPTIPHOR-10JJN · Traditional | 08/10/1984SE |
| K842485 | OpticlearJJN · Traditional | 08/10/1984SE |
| K823550 | Ck-Isozyme U.V. Reagent SetJHT · Traditional | 01/07/1983SE |
| K822121 | Acro PackJRL · Traditional | 08/05/1982SE |
| K821303 | Hi-Phore High Resolution ElectrophoresJJN · Traditional | 05/12/1982SE |
| K820518 | Gelman Glyco-Phore BufferJBD · Traditional | 04/09/1982SE |
| K813159 | Vacushield TMJRL · Traditional | 12/08/1981SE |
| K812539 | Pre-Bypass FilterKRJ · Traditional | 10/13/1981SE |
| K812253 | Gelman Ig-Fix KitCZP · Traditional | 09/01/1981SE |
| K811100 | Gelman Electrophoresis ControlJJY · Traditional | 05/01/1981SE |
| K810829 | AcrodiscJRL · Traditional | 04/08/1981SE |
| K810047 | Autophor 128JBD · Traditional | 02/05/1981SE |
| K802765 | Acrodisc Filter AssemblyFPB · Traditional | 01/21/1981SE |
| K801378 | Hipp Buffer(Non-Barbital), P/NJJN · Traditional | 07/14/1980SE |
| K791606 | Gelman Lipoprotein FRS Set. P/N 51213JHO · Traditional | 09/17/1979SE |
| K791111 | Automated Electrophoreses MachineJJN · Traditional | 07/30/1979SE |
| K790791 | Electrophoresis Reagent Set, HDLLBT · Traditional | 06/15/1979SE |