Hypoguard USA, Inc.
United StatesFDA applicant, unverified
- Devices
- 9
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Express Blood Glucose Monitoring System Ref K024347
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
2003
- 26 Nov 2003 Z-0275-04 Unclassified (pre-2012) Terminated When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
- 26 Nov 2003 Z-0276-04 Unclassified (pre-2012) Terminated When actual blood glucose levels are in the low end of the blood glucose range, the recalled test strips may provide inaccurately high readings.
Frequently asked questions
How many devices does Hypoguard USA, Inc. have in the registry?
The registry currently lists 9 devices for Hypoguard USA, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hypoguard USA, Inc.'s devices?
Among its 9 most recently registered devices, Hypoguard USA, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Hypoguard USA, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Hypoguard USA, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Hypoguard USA, Inc.?
FDA recall records list 2 recalls initiated by Hypoguard USA, Inc., the most recent initiated on 26 Nov 2003. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Hypoguard USA, Inc. in the registry?
The most recently registered devices listed for Hypoguard USA, Inc. include HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM, MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM, GLUCOBALANCE DATA MANAGEMENT SOFTWARE, MODEL 555020 and DIASCREEN 50 URINE CHEMISTRY ANALYZER, MODEL # 1242-00; DIASCREEN REAGENT STRIP FOR URINALYSIS, CAT. # D11000.