Capillarys Urine
FDA 510(k) K080916 · Sebia
510(k) numberK080916
Submission
- Device name
- Capillarys Urine
- Applicant
- Sebia
Norcross, GA, US - Received
- April 2, 2008
- Decision date
- July 1, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JKM – Immunochemical, Bence-Jones Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5150
- Specialty
- Immunology
Other 510(k)s with product code JKM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K070486 | Capillarys Urine (PN 2012)JKM · Traditional | Sebia, Inc. | 12/21/2007SE |
| K050119 | Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by…JKM · Traditional | Beckman Coulter, Inc. | 05/06/2005SE |
| K972591 | Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones KitJKM · Traditional | Morax | 03/04/1998SE |
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| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | 12/14/2018SE |
| K171861 | CAPILLARYS Hb A1cPDJ · Traditional | 02/07/2018SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | 01/11/2018SE |
| K171537 | CAPI 3 Hb A1cPDJ · Traditional | 09/12/2017SE |
Questions and answers
When was Capillarys Urine cleared by the FDA?
Capillarys Urine (K080916) received a 510(k) decision of Substantially Equivalent on July 1, 2008, 90 days after the submission was received.
What is the product code of K080916?
The FDA product code is JKM – Immunochemical, Bence-Jones Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5150.