Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-LEVEL
FDA 510(k) K072257 · More Diagnostics
510(k) numberK072257
Submission
- Device name
- Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-LEVEL
- Applicant
- More Diagnostics
Los Osos, CA, US - Received
- August 13, 2007
- Decision date
- January 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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More from Roche Diagnostic Systems, Inc.
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|---|---|---|
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| K982845 | Cardiac Markers Control (Single Use)-Levels, 1,2,3, Models Number 175-1, 175-2, 175-3JJT · Traditional | 08/21/1998SE |
| K980331 | Immunosuppressant (Whole Blood) Control, Level 1 250-1, Immunosuppressant (Whole Bloos)…DIF · Traditional | 03/16/1998SE |
| K972976 | Cardiac Markers Control - Level 1, Level 2, Level 3, Tri-LevelJJT · Traditional | 08/29/1997SE |
| K970778 | Lead Control (Whole Blood) Levels 1,2,3,4JJX · Traditional | 04/17/1997SE |
| K946193 | Fibrinogen Control (Human) Level 1, 2, 3GIL · Traditional | 08/24/1995SE |
| K943571 | Multi-Level Control for Fibrin Degradation ProductsDAP · Traditional | 06/15/1995SE |
| K944999 | Serum Bilirubin Control- Level 1, 2 and 3JJX · Traditional | 06/06/1995SE |
| K941876 | Whole Blood Volatiles Control, Levels 1 and 2JJY · Traditional | 07/28/1994SE |
| K941698 | Serum Volatiles Control - Levels 1 and 2JJY · Traditional | 07/28/1994SE |
Questions and answers
When was Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-LEVEL cleared by the FDA?
Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-LEVEL (K072257) received a 510(k) decision of Substantially Equivalent on January 30, 2008, 170 days after the submission was received.
What is the product code of K072257?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.