Direct LDL Cholesterol Immunoseparation Reagent Kit
FDA 510(k) K943150 · Genzyme Corp.
510(k) numberK943150
Submission
- Device name
- Direct LDL Cholesterol Immunoseparation Reagent Kit
- Applicant
- Genzyme Corp.
Cambridge, MA, US - Received
- June 30, 1994
- Decision date
- March 15, 1995
- 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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Questions and answers
When was Direct LDL Cholesterol Immunoseparation Reagent Kit cleared by the FDA?
Direct LDL Cholesterol Immunoseparation Reagent Kit (K943150) received a 510(k) decision of Substantially Equivalent on March 15, 1995, 258 days after the submission was received.
What is the product code of K943150?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.