Capillarys Urine (PN 2012)
FDA 510(k) K070486 · Sebia, Inc.
510(k) numberK070486
Submission
- Device name
- Capillarys Urine (PN 2012)
- Applicant
- Sebia, Inc.
Norcross, GA, US - Received
- February 20, 2007
- Decision date
- December 21, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|---|
| K080916 | Capillarys UrineJKM · Special | Sebia | 07/01/2008SE |
| 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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Questions and answers
When was Capillarys Urine (PN 2012) cleared by the FDA?
Capillarys Urine (PN 2012) (K070486) received a 510(k) decision of Substantially Equivalent on December 21, 2007, 304 days after the submission was received.
What is the product code of K070486?
The FDA product code is JKM – Immunochemical, Bence-Jones Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5150.