Serum Volatiles Control - Levels 1 and 2
FDA 510(k) K941698 · More Diagnostics
510(k) numberK941698
Submission
- Device name
- Serum Volatiles Control - Levels 1 and 2
- Applicant
- More Diagnostics
Los Osos, CA, US - Received
- April 6, 1994
- Decision date
- July 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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More from Aalto Scientific, Ltd.
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| K050125 | Rap/Tac/Csa Control - Level 1,2,3,4JJY · Traditional | 03/18/2005SE |
| 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 |
Questions and answers
When was Serum Volatiles Control - Levels 1 and 2 cleared by the FDA?
Serum Volatiles Control - Levels 1 and 2 (K941698) received a 510(k) decision of Substantially Equivalent on July 28, 1994, 113 days after the submission was received.
What is the product code of K941698?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.