Spotchem HDL, Total Cholesterol and Triglyceride Reagent Tests and Panel
FDA 510(k) K042443 · Arkray, Inc.
510(k) numberK042443
Submission
- Device name
- Spotchem HDL, Total Cholesterol and Triglyceride Reagent Tests and Panel
- Applicant
- Arkray, Inc.
Cortlandt Manor, NY, US - Received
- September 9, 2004
- Decision date
- November 24, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
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Questions and answers
When was Spotchem HDL, Total Cholesterol and Triglyceride Reagent Tests and Panel cleared by the FDA?
Spotchem HDL, Total Cholesterol and Triglyceride Reagent Tests and Panel (K042443) received a 510(k) decision of Substantially Equivalent on November 24, 2004, 76 days after the submission was received.
What is the product code of K042443?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.