Rep SP Electrophoresis System Cat No. 3170
FDA 510(k) K881852 · Helena Laboratories
510(k) numberK881852
Submission
- Device name
- Rep SP Electrophoresis System Cat No. 3170
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- May 2, 1988
- Decision date
- July 8, 1988
- 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 |
| 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 |
| K842560 | OPTIPHOR-10JJN · Traditional | Gelman Sciences, Inc. | 08/10/1984SE |
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Questions and answers
When was Rep SP Electrophoresis System Cat No. 3170 cleared by the FDA?
Rep SP Electrophoresis System Cat No. 3170 (K881852) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 67 days after the submission was received.
What is the product code of K881852?
The FDA product code is JJN – Apparatus, Electrophoresis, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2485.