Serum Potassium Reagent Set
FDA 510(k) K861713 · Sterling Diagnostics, Inc.
510(k) numberK861713
Submission
- Device name
- Serum Potassium Reagent Set
- Applicant
- Sterling Diagnostics, Inc.
Sterling Heights, MI, US - Received
- May 5, 1986
- Decision date
- May 23, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEJ – Tetraphenyl Borate, Colorimetry, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CEJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K043267 | Potassium Test Kit and Electrolyte Cal 1 and 2CEJ · Traditional | Randox Laboratories, Ltd. | 02/10/2005SE |
| K943026 | Potassium QvetCEJ · Traditional | Prisma Systems | 12/09/1994SE |
| K904033 | Reflotron Potassium Test TabsCEJ · Traditional | Boehringer Mannheim Corp. | 11/06/1990SE |
| K902574 | Potassium Reagent SetCEJ · Traditional | Tech-Co, Inc. | 07/10/1990SE |
| K883586 | Technicon RA-100 System PotassiumCEJ · Traditional | Technicon Instruments Corp. | 11/29/1988SE |
| K883585 | Technicon Assist PotassiumCEJ · Traditional | Technicon Instruments Corp. | 11/29/1988SE |
| K881440 | Iq PotassiumCEJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 05/27/1988SE |
| K880339 | Easy-Test Potassium K Item Number 19XXXCEJ · Traditional | Em Diagnostic Systems, Inc. | 02/25/1988SE |
| K863486 | Potassium TestCEJ · Traditional | Sclavo, Inc. | 09/29/1986SE |
| K853404 | Qca Potassium Test KitCEJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/23/1985SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | 07/07/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
Questions and answers
When was Serum Potassium Reagent Set cleared by the FDA?
Serum Potassium Reagent Set (K861713) received a 510(k) decision of Substantially Equivalent on May 23, 1986, 18 days after the submission was received.
What is the product code of K861713?
The FDA product code is CEJ – Tetraphenyl Borate, Colorimetry, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.