Potassium Reagent Set
FDA 510(k) K813608 · Diagnostic Specialties
510(k) numberK813608
Submission
- Device name
- Potassium Reagent Set
- Applicant
- Diagnostic Specialties
Mchenry, IL, US - Received
- December 29, 1981
- Decision date
- January 22, 1982
- 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 |
| K861713 | Serum Potassium Reagent SetCEJ · Traditional | Sterling Diagnostics, Inc. | 05/23/1986SE |
More from Sterling Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K971458 | Enzip Immunoturbidimetric Microalbumin Assay KitJIQ · Traditional | 09/02/1997SE |
| K941001 | Enzip Immunoturbidmetric Fibrinogen Assay KitGIS · Traditional | 08/30/1994SE |
| K930823 | Protein-Bound Glucose Assayn KitLCP · Traditional | 08/19/1993SE |
| K922032 | Enzip Urinary Microalbumin TestJIR · Traditional | 07/30/1992SE |
| K831180 | Pregna-Cert, Slide Pregnancy TestJHJ · Traditional | 05/27/1983SE |
| K823109 | Generic Pregnancy TestLCX · Traditional | 11/10/1982SE |
| K813412 | Glucose Enzyme-Color Reagent SetCGA · Traditional | 12/31/1981SE |
Questions and answers
When was Potassium Reagent Set cleared by the FDA?
Potassium Reagent Set (K813608) received a 510(k) decision of Substantially Equivalent on January 22, 1982, 24 days after the submission was received.
What is the product code of K813608?
The FDA product code is CEJ – Tetraphenyl Borate, Colorimetry, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.