Metrika, Inc.
Medical device manufacturer in Sunnyvale, CA.
11510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K051321 | InviewLCP · Special | 06/13/2005SE |
| K033847 | A1CNOW for Home and Professional UseLCP · Special | 12/23/2003SE |
| K022661 | A1CNOW for Home UseLCP · Traditional | 12/13/2002SE |
| K020235 | A1CNOW for Professional UseLCP · Special | 02/15/2002SE |
| K020234 | A1CNOW for RX Home UseLCP · Special | 02/15/2002SE |
| K000885 | DRX HBA1C - for Prescription Home UseLCP · Traditional | 09/26/2000SE |
| K000887 | DRX HBA1CLCP · Traditional | 07/26/2000SE |
| K992997 | Osteomark NTX PocJMM · Traditional | 11/09/1999SE |
| K991532 | DRX Qt. HCGDHA · Traditional | 09/17/1999SE |
| K984530 | DRX NTX or, Osteomark NTX Direct ResponseJFY · Traditional | 08/10/1999SE |
| K991917 | Osteomark NTX Point of Care (Poc) Control SetJJW · Traditional | 07/12/1999SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0289-2008 | A1CNOW+ with sampler 10-Test Kits (Product No: 3022), Metrika, Inc., Sunnyvale, CA…Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device… | 08/31/2007Terminated |