General Procedure Agarose Film
FDA 510(k) K802396 · Electrophoresis Corp. of America
510(k) numberK802396
Submission
- Device name
- General Procedure Agarose Film
- Applicant
- Electrophoresis Corp. of America
Mchenry, IL, US - Received
- October 2, 1980
- Decision date
- November 26, 1980
- 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 |
|---|---|---|
| K792553 | Agarose Barbital-Edta BufferJJN · Traditional | 01/29/1980SE |
| K792551 | Alkaline Phosphatase ReagentCJH · Traditional | 01/29/1980SE |
| K792548 | Alkaline Phosphatase MarkerCIN · Traditional | 01/29/1980SE |
| K792547 | Agarose Barbital BufferJJN · Traditional | 01/29/1980SE |
| K792574 | Mopso BufferJCC · Traditional | 01/21/1980SE |
| K792550 | Ponceau S Stain SetKQC · Traditional | 01/16/1980SE |
| K792552 | Amido Black 10B StainHZZ · Traditional | 12/18/1979SE |
| K792549 | Fat Red 7B Stain SetHYD · Traditional | 12/18/1979SE |
| K791657 | LDH Isoenzyme ReagentCFE · Traditional | 09/17/1979SE |
| K791656 | Enzyme Stabilizing Reagent (Esr)CFE · Traditional | 09/17/1979SE |
Questions and answers
When was General Procedure Agarose Film cleared by the FDA?
General Procedure Agarose Film (K802396) received a 510(k) decision of Substantially Equivalent on November 26, 1980, 55 days after the submission was received.
What is the product code of K802396?
The FDA product code is JJN – Apparatus, Electrophoresis, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2485.