Spinal Fluid Control
FDA 510(k) K851820 · Irvine Scientific
510(k) numberK851820
Submission
- Device name
- Spinal Fluid Control
- Applicant
- Irvine Scientific
Santa Ana, CA, US - Received
- April 26, 1985
- Decision date
- July 15, 1985
- 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 |
|---|---|---|
| K160006 | Vit Kit-Freeze Oocytes, Embryos and PN zygotes Vitrification Freeze Kit, Vit Kit-Thaw…MQL · Traditional | 05/04/2016SE |
| K914541 | Sperm Maintenance Medium with GlycerolMFD · Traditional | 02/03/1994SE |
| K900316 | Modified Ham's F-10 Medium and Medium-HepesHDR · Traditional | 04/16/1990SE |
| K894432 | Modified Ham's F-10 W/AlbuminHDR · Traditional | 09/22/1989SE |
| K894405 | HTF with Albumin (Catalog No. 9994)HDR · Traditional | 09/22/1989SE |
| K874668 | Sperm Washing Medium #9983 & Modified #9984HDR · Traditional | 03/31/1988SE |
| K872203 | Cat. #9972 Refrigeration Medium (Test Yolk Buffer)HDR · Traditional | 08/14/1987SE |
| K872088 | Freezing Medium (Test Yolk Buffer W/Glycerol)HDR · Traditional | 08/14/1987SE |
| K872102 | Sperm Washing Medium #9932HDR · Traditional | 07/16/1987SE |
| K871577 | HTF Medium and Modified HTF Medium-HepesHDR · Traditional | 07/15/1987SE |
Questions and answers
When was Spinal Fluid Control cleared by the FDA?
Spinal Fluid Control (K851820) received a 510(k) decision of Substantially Equivalent on July 15, 1985, 80 days after the submission was received.
What is the product code of K851820?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.