Elevated Lipid Control
FDA 510(k) K792375 · Environmental Chemical Specialties
510(k) numberK792375
Submission
- Device name
- Elevated Lipid Control
- Applicant
- Environmental Chemical Specialties
Mchenry, IL, US - Received
- November 26, 1979
- Decision date
- December 6, 1979
- 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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| 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 |
|---|---|---|
| K812635 | Anemia ControlJJY · Traditional | 10/02/1981SE |
| K811810 | Uric Acid TestKNK · Traditional | 07/15/1981SE |
| K811811 | TDM Anti-Convulsant Control Levels I-IiDIF · Traditional | 07/10/1981SE |
| K811809 | Anti-Arrhythmic Control Levels I & IIDIF · Traditional | 07/10/1981SE |
| K803089 | Gamma-Glutamyl Transpeptidase (GGT)JPZ · Traditional | 01/02/1981SE |
| K792377 | Carcinoembryonic Antigen (Cea) ControlDHX · Traditional | 09/26/1980SE |
| K801854 | Spinal Fluid Control(Human)JJX · Traditional | 09/16/1980SE |
| K801061 | Total Protein TestCEK · Traditional | 07/21/1980SE |
| K792376 | Quantitative Control Urine II (Human)JJW · Traditional | 12/06/1979SE |
| K792374 | Quantitative Control Urine I (Human)JJW · Traditional | 12/06/1979SE |
Questions and answers
When was Elevated Lipid Control cleared by the FDA?
Elevated Lipid Control (K792375) received a 510(k) decision of Substantially Equivalent on December 6, 1979, 10 days after the submission was received.
What is the product code of K792375?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.