Ez LDL Cholesterol Test System
FDA 510(k) K993741 · Sigma Diagnostics, Inc.
510(k) numberK993741
Submission
- Device name
- Ez LDL Cholesterol Test System
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- November 4, 1999
- Decision date
- July 3, 2000
- 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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| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
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| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
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Questions and answers
When was Ez LDL Cholesterol Test System cleared by the FDA?
Ez LDL Cholesterol Test System (K993741) received a 510(k) decision of Substantially Equivalent on July 3, 2000, 242 days after the submission was received.
What is the product code of K993741?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.