S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG)
FDA 510(k) K091413 · Alfa Wassermann, Inc.
510(k) numberK091413
Submission
- Device name
- S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG)
- Applicant
- Alfa Wassermann, Inc.
West Caldwell, NJ, US - Received
- May 13, 2009
- Decision date
- October 26, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K091544 | S-Test Lactate Dehydrogenase (LD), Model RC 0017CFJ · Traditional | 09/09/2009SE |
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Questions and answers
When was S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG) cleared by the FDA?
S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015, S-Test Triglycerides (TG) (K091413) received a 510(k) decision of Substantially Equivalent on October 26, 2009, 166 days after the submission was received.
What is the product code of K091413?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.