Normal Urine Control
FDA 510(k) K833192 · Biosan Laboratories, Inc.
510(k) numberK833192
Submission
- Device name
- Normal Urine Control
- Applicant
- Biosan Laboratories, Inc.
Mchenry, IL, US - Received
- September 19, 1983
- Decision date
- December 8, 1983
- 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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| 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 |
|---|---|---|
| K860642 | Photron Visual Field AnalyzerHOM · Traditional | 04/15/1986SE |
| K853812 | Photron Neurovisual Stimulator(Modification)HLX · Traditional | 11/01/1985SE |
| K832763 | Tobramycin ReagentKLB · Traditional | 03/23/1984SE |
| K833193 | Radioimmunoassay, Thyroid Stimu. HormoneJLW · Traditional | 02/04/1984SE |
| K834023 | Bio-Science Laboratories T4 ReagentCDX · Traditional | 01/24/1984SE |
| K833318 | Normal Goat SerumDHX · Traditional | 01/03/1984SE |
| K833320 | Amberlite CG50 Resin, 100-200 MeshKEA · Traditional | 12/08/1983SE |
| K833191 | Abnormal Urine ControlJJY · Traditional | 12/08/1983SE |
| K833319 | Bio-Rex 70 Resin 100-200 Mesh PH6.2KEA · Traditional | 11/03/1983SE |
Questions and answers
When was Normal Urine Control cleared by the FDA?
Normal Urine Control (K833192) received a 510(k) decision of Substantially Equivalent on December 8, 1983, 80 days after the submission was received.
What is the product code of K833192?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.