CLP Comprehensive Lipid Control-Hr
FDA 510(k) K896247 · Creative Laboratory Products, Inc.
510(k) numberK896247
Submission
- Device name
- CLP Comprehensive Lipid Control-Hr
- Applicant
- Creative Laboratory Products, Inc.
Indianapolis, IN, US - Received
- October 30, 1989
- Decision date
- January 10, 1990
- 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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| 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 |
|---|---|---|
| K950589 | CLP High Level High Density Lipo Protein Cholesterol Control-HlJJX · Traditional | 03/20/1995SE |
| K942284 | CLP Total Iron and Uibc/Tibc Linearity Control SetJJX · Traditional | 08/26/1994SE |
| K922995 | Lipid ControlsJJX · Traditional | 08/12/1992SE |
| K913427 | Sickle Hemoglobin (Hba/S) Control SetJCM · Traditional | 11/19/1991SE |
| K913371 | Total Iron and Unsat Iron Bind Capac/Iron Bind CalJIT · Traditional | 11/08/1991SE |
| K913585 | Lipase Linearity ControlJJX · Traditional | 10/21/1991SE |
| K913224 | Lipid Linearity ControlsJJY · Traditional | 09/25/1991SE |
| K913496 | Cholinesterase Linearity ControlJJX · Traditional | 09/11/1991SE |
| K912823 | High Density Lipoprotein CholesterolLBR · Traditional | 08/16/1991SE |
| K912725 | Total Iron & Unsat Iron Bind Cap/Iron Bind ControlJJY · Traditional | 07/30/1991SE |
Questions and answers
When was CLP Comprehensive Lipid Control-Hr cleared by the FDA?
CLP Comprehensive Lipid Control-Hr (K896247) received a 510(k) decision of Substantially Equivalent on January 10, 1990, 72 days after the submission was received.
What is the product code of K896247?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.