510(k) K062195 ยท NBW System, Test, Blood Glucose, Over The Counter
MODIFICATION TO ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM
| Applicant | Lifescan, Inc., Milpitas CA, US |
| Decision | Substantially Equivalent, Aug 16, 2006 |
| Received | Aug 1, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062195
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 16, 2021 | Cardinal Health Inc. ONETOUCH ULTRA BLUE TEST STRIPS 100 COUNT
Item Number: 2990174 Open, Classified |
NBW | None listed |
| Mar 16, 2021 | Cardinal Health Inc. ONETOUCH ULTRA TEST STRIPS 25 COUNT
Item Number: 3510443 Open, Classified |
NBW | None listed |
| Apr 17, 2013 | Lifescan Inc LifeScan brand OneTouch Ultra Control Solution, Part Numbers/Model Numbers: 01045808, 02141603.
Testing of Blood Glucose Levels. Terminated |
JJX | None listed |
| Oct 1, 2010 | Lifescan Inc One Touch Ultra Test Strips, Part Number 020-245-32, lot number 2964512, Manufactured by LifeScan Inc., Milpitas, CA. Terminated |
NBW | None listed |
| Nov 21, 2008 | Lifescan Inc One Touch Ultra Test Strips, part number 020-994-02, manufactured by LifeScan Inc, Milpitas, CA, 25 count.
Intended to be used for quantitative measurement of glucose in fresh capillary whole blood. Terminated |
NBW | None listed |
| Jul 13, 2007 | Lifescan Inc OneTouch Ultra Test strip, a component of the following OneTouch Ultra Glucose monitoring systems: a)OneTouch Ultra, b) OneTouch InDuo, c) OneTouch Ultra2, d) OneTouch UltraMini, e) OneTouch UltraSma Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.