Sodium and Potassium by Ion Selective
FDA 510(k) K873074 · American Monitor Corp.
510(k) numberK873074
Submission
- Device name
- Sodium and Potassium by Ion Selective
- Applicant
- American Monitor Corp.
Indianapolis, IN, US - Received
- August 6, 1987
- Decision date
- October 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGS – Electrode, Ion Specific, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
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| K895423 | Access Chemistry AnalyzerJJE · Traditional | 10/04/1989SE |
| K893137 | Excel (TM) Chemistry AnalyzerJJE · Traditional | 08/10/1989SE |
| K892331 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 06/20/1989SE |
| K893479 | Cholesterol Reagent SetCHH · Traditional | 06/19/1989SE |
| K892002 | Neochrome(R) III GlucoseCGA · Traditional | 06/12/1989SE |
| K890312 | Gamma-GlutamyltransferaseJQB · Traditional | 03/24/1989SE |
| K890034 | Photometric Method, Iron (Non-Heme) (75JIY)JIY · Traditional | 02/03/1989SE |
Questions and answers
When was Sodium and Potassium by Ion Selective cleared by the FDA?
Sodium and Potassium by Ion Selective (K873074) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 75 days after the submission was received.
What is the product code of K873074?
The FDA product code is JGS – Electrode, Ion Specific, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.