N-Geneous Ldl-St Cholesterol Reagent, N-Geneous Ldl-St Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set
FDA 510(k) K992766 · Genzyme Corp.
510(k) numberK992766
Submission
- Device name
- N-Geneous Ldl-St Cholesterol Reagent, N-Geneous Ldl-St Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set
- Applicant
- Genzyme Corp.
Cambridge, MA, US - Received
- August 17, 1999
- Decision date
- October 18, 1999
- 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 N-Geneous Ldl-St Cholesterol Reagent, N-Geneous Ldl-St Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set cleared by the FDA?
N-Geneous Ldl-St Cholesterol Reagent, N-Geneous Ldl-St Cholesterol Calibrator, Genzyme LDL Cholesterol Control Set (K992766) received a 510(k) decision of Substantially Equivalent on October 18, 1999, 62 days after the submission was received.
What is the product code of K992766?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.