Technicon RA-100 System Potassium
FDA 510(k) K883586 · Technicon Instruments Corp.
510(k) numberK883586
Submission
- Device name
- Technicon RA-100 System Potassium
- Applicant
- Technicon Instruments Corp.
Tarrytown, NY, US - Received
- August 23, 1988
- Decision date
- November 29, 1988
- 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 |
| 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 |
| K853404 | Qca Potassium Test KitCEJ · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/23/1985SE |
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| K903825 | Drug of Abuse Analysis SystemDIS · Traditional | 09/27/1990SE |
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| K903305 | Technicon Chem I System Carbon Dioxide MethodKHS · Traditional | 09/27/1990SE |
| K903306 | Technicon Chem I System Magnesium MethodJGJ · Traditional | 08/29/1990SE |
| K901410 | Technicon RA-2000(TM) SystemJJC · Traditional | 07/17/1990SE |
Questions and answers
When was Technicon RA-100 System Potassium cleared by the FDA?
Technicon RA-100 System Potassium (K883586) received a 510(k) decision of Substantially Equivalent on November 29, 1988, 98 days after the submission was received.
What is the product code of K883586?
The FDA product code is CEJ – Tetraphenyl Borate, Colorimetry, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.