Onetouch Reveal
FDA 510(k) K132618 · Lifescan, Inc.
510(k) numberK132618
Submission
- Device name
- Onetouch Reveal
- Applicant
- Lifescan, Inc.
Wayne, PA, US - Received
- August 21, 2013
- Decision date
- December 16, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRZ – Accessories, Pump, Infusion
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5725
- Specialty
- General Hospital
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More from Hospira, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K120558 | Onetouch Reveal Diabetes Management ApplicationNBW · Traditional | 02/07/2013SE |
| K093745 | One Touch Verio Blood Glucose Monitoring SystemNBW · Traditional | 02/11/2011SE |
| K082590 | Symphony Meter RemoteLZG · Traditional | 12/17/2008SE |
| K082513 | Onetouch Vita Blood Glucose Monitoring SystemNBW · Special | 10/22/2008SE |
| K081318 | Onetouch Zoom Diabetes Management ProgramNBW · Special | 06/09/2008SE |
| K073231 | Onetouch Ultralink Blood Glucose Monitoring SystemNBW · Traditional | 04/18/2008SE |
| K072543 | Onetouch Select Blood Glucose Monitoring SystemNBW · Special | 10/05/2007SE |
| K062195 | Modification to One Touch Ultra Blood Glucose Monitoring SystemNBW · Special | 08/16/2006SE |
| K061118 | Onetouch Ultramini Blood Glucose Monitoring SystemNBW · Special | 05/19/2006SE |
| K053529 | Onetouch Ultra 2 Blood Glucose Monitoring SystemNBW · Special | 01/17/2006SE |
Questions and answers
When was Onetouch Reveal cleared by the FDA?
Onetouch Reveal (K132618) received a 510(k) decision of Substantially Equivalent on December 16, 2013, 117 days after the submission was received.
What is the product code of K132618?
The FDA product code is MRZ – Accessories, Pump, Infusion, a Class II (moderate risk) device regulated under 21 CFR 880.5725.