Lipophor(Tm) Syst, Human Serum Lipoprotein Control
FDA 510(k) K883247 · Quantimetrix Medical Industries
510(k) numberK883247
Submission
- Device name
- Lipophor(Tm) Syst, Human Serum Lipoprotein Control
- Applicant
- Quantimetrix Medical Industries
Hawthorne, CA, US - Received
- August 2, 1988
- Decision date
- September 13, 1988
- 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 |
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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 |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K895778 | Quantimetrix Bilirubin CalibratorsJIS · Traditional | 11/14/1989SE |
| K883395 | Alkphor(Tm) System, Human Serum Alka Phos IsoenzyJJT · Traditional | 09/19/1988SE |
| K874302 | Quantimetrix Total Creatine Kinase ControlJJT · Traditional | 02/02/1988SE |
| K874890 | Quantimetrix Urine Dipstick ControlJJW · Traditional | 01/21/1988SE |
| K873011 | Quantimetrix Serum Alcohol Control Level 1 and 2LAS · Traditional | 10/29/1987SE |
| K873467 | Quantimetrix Urine Drugs of Abuse ControlDIF · Traditional | 09/29/1987SE |
| K861448 | Quantimetrix Serum Lipid Control I & II LiquidJJY · Traditional | 04/28/1986SE |
Questions and answers
When was Lipophor(Tm) Syst, Human Serum Lipoprotein Control cleared by the FDA?
Lipophor(Tm) Syst, Human Serum Lipoprotein Control (K883247) received a 510(k) decision of Substantially Equivalent on September 13, 1988, 42 days after the submission was received.
What is the product code of K883247?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.