Urine Magnesium Method for Technicon Chem Systems
FDA 510(k) K926144 · Heraeus Kulzer, Inc.
510(k) numberK926144
Submission
- Device name
- Urine Magnesium Method for Technicon Chem Systems
- Applicant
- Heraeus Kulzer, Inc.
Tarrytown, NY, US - Received
- December 7, 1992
- Decision date
- January 27, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JGJ – Photometric Method, Magnesium
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1495
- Specialty
- Clinical Chemistry
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| K122302 | Ace Magnesium RegentJGJ · Special | Alfa Wassermann Diagnostics Technologies, LLC | 08/27/2012SE |
| K111915 | Magnesium AssayJGJ · Traditional | Sekisui Diagnostics P.E.I., Inc. | 12/02/2011SE |
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| K091910 | Piccolo Magnesium Test SystemJGJ · Special | Abaxis, Inc. | 10/01/2009SE |
| K063208 | Magnesium Assay (XB), Models 125-12, 125-50 and 125-S7JGJ · Traditional | Diagnostic Chemicals , Ltd. | 01/19/2007SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | Clinical Data, Inc. | 03/08/2004SE |
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Questions and answers
When was Urine Magnesium Method for Technicon Chem Systems cleared by the FDA?
Urine Magnesium Method for Technicon Chem Systems (K926144) received a 510(k) decision of Substantially Equivalent on January 27, 1993, 51 days after the submission was received.
What is the product code of K926144?
The FDA product code is JGJ – Photometric Method, Magnesium, a Class I (low risk) device regulated under 21 CFR 862.1495.