Gas Trak Plus
FDA 510(k) K884977 · United Diagnostics, Inc.
510(k) numberK884977
Submission
- Device name
- Gas Trak Plus
- Applicant
- United Diagnostics, Inc.
Natick, MA, US - Received
- November 30, 1988
- Decision date
- January 27, 1989
- 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
Other 510(k)s with product code JJY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| 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 |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K862278 | Gas-TrakJJY · Traditional | 08/04/1986SE |
| K844018 | Gas Trak Brand Co-Oximeter Controls 1,2 & 3JJY · Traditional | 11/27/1984SE |
| K843986 | Stat-Trak Plus Liquid Chemistry 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 Gas Trak Plus cleared by the FDA?
Gas Trak Plus (K884977) received a 510(k) decision of Substantially Equivalent on January 27, 1989, 58 days after the submission was received.
What is the product code of K884977?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.