Iq Potassium
FDA 510(k) K881440 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK881440
Submission
- Device name
- Iq Potassium
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- April 5, 1988
- Decision date
- May 27, 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 |
| K883586 | Technicon RA-100 System PotassiumCEJ · Traditional | Technicon Instruments Corp. | 11/29/1988SE |
| K883585 | Technicon Assist PotassiumCEJ · Traditional | Technicon Instruments Corp. | 11/29/1988SE |
| 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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Questions and answers
When was Iq Potassium cleared by the FDA?
Iq Potassium (K881440) received a 510(k) decision of Substantially Equivalent on May 27, 1988, 52 days after the submission was received.
What is the product code of K881440?
The FDA product code is CEJ – Tetraphenyl Borate, Colorimetry, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.