UREA-L3K Assay, Catalogue Number 283-17/10/30/50
FDA 510(k) K993178 · Diagnostic Chemicals , Ltd.
510(k) numberK993178
Submission
- Device name
- UREA-L3K Assay, Catalogue Number 283-17/10/30/50
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- September 23, 1999
- Decision date
- October 18, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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Questions and answers
When was UREA-L3K Assay, Catalogue Number 283-17/10/30/50 cleared by the FDA?
UREA-L3K Assay, Catalogue Number 283-17/10/30/50 (K993178) received a 510(k) decision of Substantially Equivalent on October 18, 1999, 25 days after the submission was received.
What is the product code of K993178?
The FDA product code is CDQ – Urease And Glutamic Dehydrogenase, Urea Nitrogen, a Class II (moderate risk) device regulated under 21 CFR 862.1770.