Sodium/Potassium Reagent Sys
FDA 510(k) K840216 · Sclavo, Inc.
510(k) numberK840216
Submission
- Device name
- Sodium/Potassium Reagent Sys
- Applicant
- Sclavo, Inc.
Mchenry, IL, US - Received
- January 19, 1984
- Decision date
- March 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGT – Flame Photometry, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896829 | Technicon Ra Systems Sodium (Colorimetric Method)JGT · Traditional | Technicon Instruments Corp. | 02/23/1990SE |
| K891574 | Lithium Concentrate #SR1031, Na/K Standards SR1030JGT · Traditional | Em Diagnostic Systems, Inc. | 06/09/1989SE |
| K841610 | Components for Potassium, Sodium ChloJGT · Traditional | Shaban Mfg. Co. | 05/25/1984SE |
| K834248 | Parallel Flame Photometer & SodiumJGT · Traditional | American Monitor Corp. | 01/30/1984SE |
| K811886 | Cesium Diluent 7.5MJGT · Traditional | Gilford Diagnostics | 07/23/1981SE |
| K801892 | Klinar Reagent Pak, #36010JGT · Traditional | Hi Chem, Inc. | 10/23/1980SE |
| K770774 | Lytetek SystemJGT · Traditional | Boehringer Mannheim Corp. | 07/11/1977SE |
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| K880049 | Cholinesterase - Butyrythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
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| K884035 | Saitron 430 Random Access Chemistry AnalyzerJJE · Traditional | 12/29/1988SE |
Questions and answers
When was Sodium/Potassium Reagent Sys cleared by the FDA?
Sodium/Potassium Reagent Sys (K840216) received a 510(k) decision of Substantially Equivalent on March 19, 1984, 60 days after the submission was received.
What is the product code of K840216?
The FDA product code is JGT – Flame Photometry, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.