Parallel Flame Photometer & Sodium
FDA 510(k) K834248 · American Monitor Corp.
510(k) numberK834248
Submission
- Device name
- Parallel Flame Photometer & Sodium
- Applicant
- American Monitor Corp.
Mchenry, IL, US - Received
- December 7, 1983
- Decision date
- January 30, 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 |
| K840216 | Sodium/Potassium Reagent SysJGT · Traditional | Sclavo, Inc. | 03/19/1984SE |
| 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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Questions and answers
When was Parallel Flame Photometer & Sodium cleared by the FDA?
Parallel Flame Photometer & Sodium (K834248) received a 510(k) decision of Substantially Equivalent on January 30, 1984, 54 days after the submission was received.
What is the product code of K834248?
The FDA product code is JGT – Flame Photometry, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.