Urease & Glutamate Dehydrogenase, Urea Nitrogen
FDA 510(k) K853102 · Diagnostic Chemicals, Ltd. (Usa)
510(k) numberK853102
Submission
- Device name
- Urease & Glutamate Dehydrogenase, Urea Nitrogen
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
Charlottestown,Pei,Canada, CA - Received
- July 23, 1985
- Decision date
- August 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1770
- Specialty
- Clinical Chemistry
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| K925877 | Dc-Uibc-CalJIS · Traditional | 03/18/1993SE |
| K912825 | Magnesium Assay Kit, Cat.# 100-12JGJ · Traditional | 07/26/1991SE |
| K895964 | DCL Syphilis-M Catalog No. 600-80LIP · Traditional | 01/08/1991SE |
| K895965 | DCL - Syphilis-G Assay Catalog No. 600-70LIP · Traditional | 12/26/1990SE |
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Questions and answers
When was Urease & Glutamate Dehydrogenase, Urea Nitrogen cleared by the FDA?
Urease & Glutamate Dehydrogenase, Urea Nitrogen (K853102) received a 510(k) decision of Substantially Equivalent on August 2, 1985, 10 days after the submission was received.
What is the product code of K853102?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.