S-Test LDL Cholesterol (LDL), Model RC0022
FDA 510(k) K091333 · Alfa Wassermann, Inc.
510(k) numberK091333
Submission
- Device name
- S-Test LDL Cholesterol (LDL), Model RC0022
- Applicant
- Alfa Wassermann, Inc.
West Caldwell, NJ, US - Received
- May 6, 2009
- Decision date
- August 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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| K091413 | S-Test Cholesterol (Cho), Model RC0009, S-Test HDL Cholesterol (HDL), Model RC0015…CHH · Traditional | 10/26/2009SE |
| K091544 | S-Test Lactate Dehydrogenase (LD), Model RC 0017CFJ · Traditional | 09/09/2009SE |
| K080073 | S-Test Creatinine (Cre)JFY · Traditional | 06/30/2008SE |
| K063306 | Ace Hemoglobin A1C Reagent, Model ACI-21, Hemoglobin A1C Calibrators, Model S2-72…LCP · Traditional | 04/17/2007SE |
Questions and answers
When was S-Test LDL Cholesterol (LDL), Model RC0022 cleared by the FDA?
S-Test LDL Cholesterol (LDL), Model RC0022 (K091333) received a 510(k) decision of Substantially Equivalent on August 3, 2009, 89 days after the submission was received.
What is the product code of K091333?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.