Lithium Concentrate for a Flame Photometer
FDA 510(k) K895718 · Data Medical Associates, Inc.
510(k) numberK895718
Submission
- Device name
- Lithium Concentrate for a Flame Photometer
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- September 25, 1989
- Decision date
- October 19, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGM – Flame Photometry, Potassium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1600
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K862300 | Amresco Flow Pac Sodium Potassium ReagentJGM · Traditional | Amresco, Inc. | 07/29/1986SE |
| K831300 | MSI-NAK-50 Test KitJGM · Traditional | Medical Specialties, Inc. | 07/18/1983SE |
| K810253 | Sodium & Potassium Test KitJGM · Traditional | Mallinckrodt Critical Care | 02/10/1981SE |
| K771068 | Triglyceride KitJGM · Traditional | Environmental Chemical Specialties | 07/12/1977SE |
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| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | 02/29/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | 12/20/1995SE |
| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | 10/03/1995SE |
| K946161 | Dma Total Cholesterol ProcedureCHH · Traditional | 08/23/1995SE |
| K946354 | Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional | 05/08/1995SE |
| K946355 | Dma Albumin ProcedureCIX · Traditional | 03/01/1995SE |
Questions and answers
When was Lithium Concentrate for a Flame Photometer cleared by the FDA?
Lithium Concentrate for a Flame Photometer (K895718) received a 510(k) decision of Substantially Equivalent on October 19, 1989, 24 days after the submission was received.
What is the product code of K895718?
The FDA product code is JGM – Flame Photometry, Potassium, a Class II (moderate risk) device regulated under 21 CFR 862.1600.