Urea Assay Kit
FDA 510(k) K843057 · Diagnostic Chemicals, Ltd. (Usa)
510(k) numberK843057
Submission
- Device name
- Urea Assay Kit
- Applicant
- Diagnostic Chemicals, Ltd. (Usa)
Canada, US - Received
- August 3, 1984
- Decision date
- August 27, 1984
- 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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| K895965 | DCL - Syphilis-G Assay Catalog No. 600-70LIP · Traditional | 12/26/1990SE |
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Questions and answers
When was Urea Assay Kit cleared by the FDA?
Urea Assay Kit (K843057) received a 510(k) decision of Substantially Equivalent on August 27, 1984, 24 days after the submission was received.
What is the product code of K843057?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.