Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50B
FDA 510(k) K041928 · Diagnostic Chemicals , Ltd.
510(k) numberK041928
Submission
- Device name
- Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50B
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E., CA - Received
- July 19, 2004
- Decision date
- November 23, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LBS – Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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| K100550 | Poly-Chem 90 Direct HDL Cholesterol, Poly-Chem 90 Direct LDL Cholesterol, Poly-Chem 90…LBS · Traditional | Polymedco, Inc. | 09/28/2010SE |
| K100010 | HDL Cholesterol (HDLX) AssayLBS · Traditional | Beckman Coulter, Inc. | 05/14/2010SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | Wako Chemicals USA, Inc. | 07/18/2008SE |
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| K041927 | Ldl/Advance Assay, Cat. No. 279-20, 279-40MRR · Traditional | 11/23/2004SE |
Questions and answers
When was Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50B cleared by the FDA?
Hdl-Advance Assay, Cat. No. 278-20, 278-50A, 278-50B (K041928) received a 510(k) decision of Substantially Equivalent on November 23, 2004, 127 days after the submission was received.
What is the product code of K041928?
The FDA product code is LBS – Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.