Eurochima Serum Protein Electrophoresis Method
FDA 510(k) K844710 · Logos Scientific, Inc.
510(k) numberK844710
Submission
- Device name
- Eurochima Serum Protein Electrophoresis Method
- Applicant
- Logos Scientific, Inc.
Henderson, NV, US - Received
- December 3, 1984
- Decision date
- January 7, 1985
- 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 |
| K842560 | OPTIPHOR-10JJN · Traditional | Gelman Sciences, Inc. | 08/10/1984SE |
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| K843375 | Elvi 655 Flame PhotometerJJO · Traditional | 05/20/1985SE |
| K843296 | Elvi 675 DigitronJJQ · Traditional | 09/13/1984SE |
| K842313 | Elvi 146 SeroscanJQT · Traditional | 09/10/1984SE |
| K842056 | Elvi 165 Proteo SeroskopJQT · Traditional | 06/22/1984SE |
| K841804 | Elvi 70 Safety ChamberJJN · Traditional | 05/31/1984SE |
| K840757 | Elvi 444 BilitronCIG · Traditional | 05/30/1984SE |
| K841288 | Elvi 18JJN · Traditional | 05/02/1984SE |
Questions and answers
When was Eurochima Serum Protein Electrophoresis Method cleared by the FDA?
Eurochima Serum Protein Electrophoresis Method (K844710) received a 510(k) decision of Substantially Equivalent on January 7, 1985, 35 days after the submission was received.
What is the product code of K844710?
The FDA product code is JJN – Apparatus, Electrophoresis, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2485.