Ameritek, Inc.
Medical device manufacturer in Seattle, WA.
17510(k) clearances
0PMA approvals
0recalls
Device types
- JHI Visual, Pregnancy Hcg, Prescription Use 2
- DKZ Enzyme Immunoassay, Amphetamine 2
- HPN Magnet, Permanent 1
- KYG Device, Irrigation, Ocular Surgery 1
- HKX Tonometer, Ac-Powered 1
- HNH Ring, Ophthalmic (Flieringa) 1
- LCX Kit, Test, Pregnancy, Hcg, Over The Counter 1
- JIL Method, Enzymatic, Glucose (Urinary… 1
- CEP Radioimmunoassay, Luteinizing Hormone 1
- LDJ Enzyme Immunoassay, Cannabinoids 1
- LAF Gas Chromatography, Methamphetamine 1
- DJG Enzyme Immunoassay, Opiates 1
- DIO Enzyme Immunoassay, Cocaine And Cocaine… 1
- KHE Reagent, Occult Blood 1
- JMT Diazo (Colorimetric), Nitrite (Urinary… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K001215 | Dbest HCG 2 Iu/Ml Test KitJHI · Abbreviated | 06/22/2000SE |
| K990873 | Dbest Urinary Tract Infection Test Kit for Home-UseJMT · Traditional | 09/01/1999SE |
| K990681 | Dbset Multidrug Screen Test KitDKZ · Traditional | 07/15/1999SE |
| K984269 | Dbest Occult Blood Test KitKHE · Traditional | 05/11/1999SE |
| K983191 | Dbest Cocaine Test KitDIO · Traditional | 11/18/1998SE |
| K983190 | Dbest Opiates Test KitDJG · Traditional | 11/18/1998SE |
| K983189 | Dbest Methamphetamines Test KitLAF · Traditional | 11/18/1998SE |
| K983188 | Dbest Tetrahydrocannabinol Test KitLDJ · Traditional | 11/18/1998SE |
| K981504 | Dbest Amphetamines Test KitDKZ · Traditional | 08/06/1998SE |
| K974508 | Dbest One-Step Ovulation TestCEP · Traditional | 02/02/1998SE |
| K973957 | Dbest One-Step HCG Serum/Urine TestJHI · Traditional | 12/17/1997SE |
| K973142 | Dbest Reagent Strip for UrinalysisJIL · Traditional | 10/20/1997SE |
| K953606 | Best Pregnancy TestLCX · Traditional | 03/22/1996SE |
| K863775 | RK Vacuum Fixation Ring SystemHNH · Traditional | 10/20/1986SE |
| K863235 | Surgical Iop MonitorHKX · Traditional | 09/25/1986SE |
| K861013 | Electrically Controlled I.V. Pole (Opthalmic)KYG · Traditional | 03/31/1986SE |
| K860960 | Rare Earth Intra-Ocular MagnetHPN · Traditional | 03/31/1986SE |