510(k) K091547 ยท NBW System, Test, Blood Glucose, Over The Counter
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
| Applicant | Nova Biomedical Corp., Walham MA, US |
| Decision | Substantially Equivalent, Jan 15, 2010 |
| Received | May 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count Retail)
Catalog Number: 43437
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plu Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count DME)
Catalog Number: 43523
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Boxed)
Catalog Number: 43590
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (100 Count Retail Canada)Catalog Number: 43955
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Vials)
Catalog Number: 43604
These strips are kitted into Nova Max Glucose Test Strip System Kits 43435 and 45507
Product Usage: The Nova Max Glucose Test Str Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (50 Count International
Catalog Number: 45512
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Ma Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials)
Catalog Number: 43435
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Glucose Test Strips (10 Count Canada)Catalog Number: 43877
Product The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, Nova Max Plus, Nova Ma Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials Canada) Catalog Number: 43861
Product usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Max, N Terminated |
NBW | None listed |
| Aug 9, 2013 | Nova Biomedical Corporation Nova Max Plus Monitor System (Kit w/10 Count Vials International)
Catalog Number: 45507
Product Usage: The Nova Max Glucose Test Strips are for use with the Nova Max Family of Glucose Monitors (Nova Terminated |
NBW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.