Sigma Diagnostics Creatinine Reagent Kit
FDA 510(k) K963534 · Sigma Diagnostics, Inc.
510(k) numberK963534
Submission
- Device name
- Sigma Diagnostics Creatinine Reagent Kit
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- September 4, 1996
- Decision date
- September 30, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGX – Alkaline Picrate, Colorimetry, Creatinine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1225
- Specialty
- Clinical Chemistry
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| K221813 | Nova Allegro UACR Assay, Nova Allegro AnalyzerCGX · Dual Track | Nova Biomedical Corporation | 11/19/2024SE |
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Questions and answers
When was Sigma Diagnostics Creatinine Reagent Kit cleared by the FDA?
Sigma Diagnostics Creatinine Reagent Kit (K963534) received a 510(k) decision of Substantially Equivalent on September 30, 1996, 26 days after the submission was received.
What is the product code of K963534?
The FDA product code is CGX – Alkaline Picrate, Colorimetry, Creatinine, a Class II (moderate risk) device regulated under 21 CFR 862.1225.