Direct LDL
FDA 510(k) K981303 · Abbott Laboratories
510(k) numberK981303
Submission
- Device name
- Direct LDL
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- April 10, 1998
- Decision date
- August 3, 1998
- 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 cleared by the FDA?
Direct LDL (K981303) received a 510(k) decision of Substantially Equivalent on August 3, 1998, 115 days after the submission was received.
What is the product code of K981303?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.