Ldl/Advance Assay, Cat. No. 279-20, 279-40
FDA 510(k) K041927 · Diagnostic Chemicals , Ltd.
510(k) numberK041927
Submission
- Device name
- Ldl/Advance Assay, Cat. No. 279-20, 279-40
- 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
- MRR – System, Test, Low Density, Lipoprotein
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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Questions and answers
When was Ldl/Advance Assay, Cat. No. 279-20, 279-40 cleared by the FDA?
Ldl/Advance Assay, Cat. No. 279-20, 279-40 (K041927) 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 K041927?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.