Hi-Phore High Resolution Electrophores
FDA 510(k) K821303 · Gelman Sciences, Inc.
510(k) numberK821303
Submission
- Device name
- Hi-Phore High Resolution Electrophores
- Applicant
- Gelman Sciences, Inc.
Mchenry, IL, US - Received
- May 4, 1982
- Decision date
- May 12, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJN – Apparatus, Electrophoresis, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2485
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924021 | Power SupplyJJN · Traditional | The Binding Site, Ltd. | 01/28/1993SE |
| K924020 | Electrophoresis TankJJN · Traditional | The Binding Site, Ltd. | 12/28/1992SE |
| K882344 | Electr-TransblotterJJN · Traditional | The W.E.P. Co. | 01/13/1989SE |
| K881852 | Rep SP Electrophoresis System Cat No. 3170JJN · Traditional | Helena Laboratories | 07/08/1988SE |
| K882163 | Helena Rep Gel ProcessorJJN · Traditional | Helena Laboratories | 06/20/1988SE |
| K873352 | Rapid Electrophoresis System (Rep)JJN · Traditional | Helena Laboratories | 09/08/1987SE |
| K864436 | Stavip 3000JJN · Traditional | Roseburg SA | 03/16/1987SE |
| K861414 | Electrophoresis Work Center (Ewc)JJN · Traditional | Helena Laboratories | 08/26/1986SE |
| K841407 | Isogel AgaroseJJN · Traditional | Fmc Corp. | 07/16/1985SE |
| K844710 | Eurochima Serum Protein Electrophoresis MethodJJN · Traditional | Logos Scientific, Inc. | 01/07/1985SE |
More from Logos Scientific, Inc.
| 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 |
Questions and answers
When was Hi-Phore High Resolution Electrophores cleared by the FDA?
Hi-Phore High Resolution Electrophores (K821303) received a 510(k) decision of Substantially Equivalent on May 12, 1982, 8 days after the submission was received.
What is the product code of K821303?
The FDA product code is JJN – Apparatus, Electrophoresis, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2485.