Cantrol Electrophoresis Control
FDA 510(k) K854931 · Canyon Diagnostics, Inc.
510(k) numberK854931
Submission
- Device name
- Cantrol Electrophoresis Control
- Applicant
- Canyon Diagnostics, Inc.
Anaheim, CA, US - Received
- December 10, 1985
- Decision date
- January 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K970248 | Cantrol Serum Iron and Total Iron Binding Capacity Test SystemJQE · Traditional | 02/11/1997SE |
| K964640 | Cantrol Iron/Tibc Controls, Level 1 and Level 2 Product Numbers: Level 1: IIBC-91 and…JJY · Traditional | 12/13/1996SE |
| K882488 | Cantrol HDL Cholesterol Precipi. Reag. and TubesLBR · Traditional | 08/15/1988SE |
| K871537 | Cantrol HDL Cholestrol Controls Levels I and IIJJY · Traditional | 05/06/1987SE |
| K855006 | Cantrol Ck/Mb ControlJJT · Traditional | 01/17/1986SE |
| K854190 | Cantrol Spinal Fluid ControlDFI · Traditional | 11/25/1985SE |
| K853603 | Cantrol Urine Dipstick Control Two LevelsJJW · Traditional | 10/08/1985SE |
| K852138 | Wescor Stain Pack for Model 7100 Aerospray Slide SIAF · Traditional | 06/13/1985SE |
Questions and answers
When was Cantrol Electrophoresis Control cleared by the FDA?
Cantrol Electrophoresis Control (K854931) received a 510(k) decision of Substantially Equivalent on January 17, 1986, 38 days after the submission was received.
What is the product code of K854931?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.