Company ยท US
Ameritek, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 2008. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 |
| DKZ | Enzyme Immunoassay, Amphetamine | 2 |
| KHE | Reagent, Occult Blood | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| HKX | Tonometer, Ac-Powered | 1 |
| HNH | Ring, Ophthalmic (Flieringa) | 1 |
| HPN | Magnet, Permanent | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 |
| JMT | Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | 1 |
| KYG | Device, Irrigation, Ocular Surgery | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 6, 2008 | K071242 | DBEST ONE STEP OCCULT BLOOD TEST KITS Ameritek USA, Inc. | KHE |
| May 4, 2007 | K061257 | DBEST HCG PANEL TEST KIT Ameritek USA, Inc. | JHI |
| Jun 22, 2000 | K001215 | DBEST HCG 2 IU/ML TEST KIT Ameritek, Inc. | JHI |
| Sep 1, 1999 | K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE Ameritek, Inc. | JMT |
| Jul 15, 1999 | K990681 | DBSET MULTIDRUG SCREEN TEST KIT Ameritek, Inc. | DKZ |
| May 11, 1999 | K984269 | DBEST OCCULT BLOOD TEST KIT Ameritek, Inc. | KHE |
| Nov 18, 1998 | K983191 | DBEST COCAINE TEST KIT Ameritek, Inc. | DIO |
| Nov 18, 1998 | K983190 | DBEST OPIATES TEST KIT Ameritek, Inc. | DJG |
| Nov 18, 1998 | K983189 | DBEST METHAMPHETAMINES TEST KIT Ameritek, Inc. | LAF |
| Nov 18, 1998 | K983188 | DBEST TETRAHYDROCANNABINOL TEST KIT Ameritek, Inc. | LDJ |
| Aug 6, 1998 | K981504 | DBEST AMPHETAMINES TEST KIT Ameritek, Inc. | DKZ |
| Feb 2, 1998 | K974508 | DBEST ONE-STEP OVULATION TEST Ameritek, Inc. | CEP |
| Dec 17, 1997 | K973957 | DBEST ONE-STEP HCG SERUM/URINE TEST Ameritek, Inc. | JHI |
| Oct 20, 1997 | K973142 | DBEST REAGENT STRIP FOR URINALYSIS Ameritek, Inc. | JIL |
| Mar 22, 1996 | K953606 | BEST PREGNANCY TEST Ameritek, Inc. | LCX |
| Oct 20, 1986 | K863775 | RK VACUUM FIXATION RING SYSTEM Ameritek, Inc. | HNH |
| Sep 25, 1986 | K863235 | SURGICAL IOP MONITOR Ameritek, Inc. | HKX |
| Mar 31, 1986 | K861013 | ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) Ameritek, Inc. | KYG |
| Mar 31, 1986 | K860960 | RARE EARTH INTRA-OCULAR MAGNET Ameritek, Inc. | HPN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||