Stat-Trak Plus Liquid Chemistry Controls 1,2 & 3
FDA 510(k) K843986 · United Diagnostics, Inc.
510(k) numberK843986
Submission
- Device name
- Stat-Trak Plus Liquid Chemistry Controls 1,2 & 3
- Applicant
- United Diagnostics, Inc.
Natick, MA, US - Received
- October 11, 1984
- Decision date
- November 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
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More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K884977 | Gas Trak PlusJJY · Traditional | 01/27/1989SE |
| K862278 | Gas-TrakJJY · Traditional | 08/04/1986SE |
| K844018 | Gas Trak Brand Co-Oximeter Controls 1,2 & 3JJY · Traditional | 11/27/1984SE |
| K831389 | Stat-Trak Liquid Electrolyte ControlJJR · Traditional | 08/10/1983SE |
| K831814 | Calibration Standard-HemoglobinKRZ · Traditional | 07/28/1983SE |
| K831813 | Co-Oximeter ControlKHG · Traditional | 07/28/1983SE |
| K831075 | Blood Gas & Flame Photometer Instru-CGC · Traditional | 06/22/1983SE |
| K820705 | Gas-Trak 2 Synthetic Blood Gas ControlJJS · Traditional | 04/01/1982SE |
| K813517 | Blood Gas Analysis, Standards ControlsCHL · Traditional | 12/31/1981SE |
| K810618 | Ampuled Flame Photometer StandardsJIS · Traditional | 03/31/1981SE |
Questions and answers
When was Stat-Trak Plus Liquid Chemistry Controls 1,2 & 3 cleared by the FDA?
Stat-Trak Plus Liquid Chemistry Controls 1,2 & 3 (K843986) received a 510(k) decision of Substantially Equivalent on November 27, 1984, 47 days after the submission was received.
What is the product code of K843986?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.