Dma Glucose Hexokinase U.V. Procedure
FDA 510(k) K952437 · Data Medical Associates, Inc.
510(k) numberK952437
Submission
- Device name
- Dma Glucose Hexokinase U.V. Procedure
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- May 25, 1995
- Decision date
- October 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CFR – Hexokinase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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| K123018 | Ace Alera Clinical Chemistry System, Ace Glucose Reagent, Ace Ion Selective Electrode…CFR · Traditional | Alfa Wassermann Diagnostic Technologies, Inc. | 04/23/2013SE |
| K120681 | Advia Chemistry GLUH_3 ReagentsCFR · Traditional | Siemens Healthcare Diagnostics, Inc. | 05/15/2012SE |
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| K971113 | Dma Triglycerides ProceduresCDT · Traditional | 05/29/1997SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | 07/01/1996SE |
| K955796 | Iron Calibrator & Calibration Verification SetJJX · Traditional | 02/29/1996SE |
| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | 02/29/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | 12/20/1995SE |
| 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 |
| K944255 | Dma Calcium Plus ProcedureCJY · Traditional | 12/06/1994SE |
Questions and answers
When was Dma Glucose Hexokinase U.V. Procedure cleared by the FDA?
Dma Glucose Hexokinase U.V. Procedure (K952437) received a 510(k) decision of Substantially Equivalent on October 3, 1995, 131 days after the submission was received.
What is the product code of K952437?
The FDA product code is CFR – Hexokinase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.