Lead Control (Whole Blood) Levels 1,2,3,4
FDA 510(k) K970778 · More Diagnostics
510(k) numberK970778
Submission
- Device name
- Lead Control (Whole Blood) Levels 1,2,3,4
- Applicant
- More Diagnostics
Los Osos, CA, US - Received
- March 4, 1997
- Decision date
- April 17, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| 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 |
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| K941698 | Serum Volatiles Control - Levels 1 and 2JJY · Traditional | 07/28/1994SE |
Questions and answers
When was Lead Control (Whole Blood) Levels 1,2,3,4 cleared by the FDA?
Lead Control (Whole Blood) Levels 1,2,3,4 (K970778) received a 510(k) decision of Substantially Equivalent on April 17, 1997, 44 days after the submission was received.
What is the product code of K970778?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.