Rdi Direct LDL Cholesterol Test
FDA 510(k) K984107 · Reference Diagnostics, Inc.
510(k) numberK984107
Submission
- Device name
- Rdi Direct LDL Cholesterol Test
- Applicant
- Reference Diagnostics, Inc.
Bedford, MA, US - Received
- November 17, 1998
- Decision date
- January 28, 1999
- 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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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K053291 | Ferritin Calibrator Set, Catalog No. 8203JIT · Abbreviated | 03/13/2006SE |
| K053211 | Rdi Hsferritin KitDBF · Traditional | 03/13/2006SE |
| K052148 | Total Iron-Binding Capacity Calibrator Set. Direct Tibc Calibrator SetJIT · Abbreviated | 11/09/2005SE |
| K030044 | Extended Range HS CRP Kit, Cat NO:9200DCK · Traditional | 09/30/2003SE |
| K030772 | Rdi Extended Range CRP Calibrator SetJIT · Abbreviated | 04/11/2003SE |
| K021609 | Rdi HS CRP KitDCK · Traditional | 06/27/2002SE |
| K021607 | Rdi HS CRP Calibrator SetJIT · Abbreviated | 06/27/2002SE |
| K000783 | Direct Tibc CalibratorJIT · Abbreviated | 05/04/2000SE |
| K000781 | Direct Tibc KitJMO · Traditional | 05/02/2000SE |
| K990216 | Magnetic Tibc KitJMO · Traditional | 02/16/1999SE |
Questions and answers
When was Rdi Direct LDL Cholesterol Test cleared by the FDA?
Rdi Direct LDL Cholesterol Test (K984107) received a 510(k) decision of Substantially Equivalent on January 28, 1999, 72 days after the submission was received.
What is the product code of K984107?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.