Lyphochek Spinal Fluid Control (Human)
FDA 510(k) K880494 · Bio-Rad
510(k) numberK880494
Submission
- Device name
- Lyphochek Spinal Fluid Control (Human)
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- February 4, 1988
- Decision date
- March 3, 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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| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
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| 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 |
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Questions and answers
When was Lyphochek Spinal Fluid Control (Human) cleared by the FDA?
Lyphochek Spinal Fluid Control (Human) (K880494) received a 510(k) decision of Substantially Equivalent on March 3, 1988, 28 days after the submission was received.
What is the product code of K880494?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.