Ameritek, Inc.
Seattle, WA, US
Ameritek, Inc. appears in FDA device records in Seattle, WA. FDA records list 17 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 17
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 17 510(k) clearances for Ameritek, Inc. between 1986 and 2000. The busiest year on record is 1998, with 6. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 4 |
| 1996 | 1 |
| 1997 | 2 |
| 1998 | 6 |
| 1999 | 3 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K001215 | DBEST HCG 2 IU/ML TEST KIT | JHI | Substantially Equivalent | |
| K990873 | DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE | JMT | Substantially Equivalent | |
| K990681 | DBSET MULTIDRUG SCREEN TEST KIT | DKZ | Substantially Equivalent | |
| K984269 | DBEST OCCULT BLOOD TEST KIT | KHE | Substantially Equivalent | |
| K983191 | DBEST COCAINE TEST KIT | DIO | Substantially Equivalent | |
| K983190 | DBEST OPIATES TEST KIT | DJG | Substantially Equivalent | |
| K983189 | DBEST METHAMPHETAMINES TEST KIT | LAF | Substantially Equivalent | |
| K983188 | DBEST TETRAHYDROCANNABINOL TEST KIT | LDJ | Substantially Equivalent | |
| K981504 | DBEST AMPHETAMINES TEST KIT | DKZ | Substantially Equivalent | |
| K974508 | DBEST ONE-STEP OVULATION TEST | CEP | Substantially Equivalent | |
| K973957 | DBEST ONE-STEP HCG SERUM/URINE TEST | JHI | Substantially Equivalent | |
| K973142 | DBEST REAGENT STRIP FOR URINALYSIS | JIL | Substantially Equivalent | |
| K953606 | BEST PREGNANCY TEST | LCX | Substantially Equivalent | |
| K863775 | RK VACUUM FIXATION RING SYSTEM | HNH | Substantially Equivalent | |
| K863235 | SURGICAL IOP MONITOR | HKX | Substantially Equivalent | |
| K861013 | ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC) | KYG | Substantially Equivalent | |
| K860960 | RARE EARTH INTRA-OCULAR MAGNET | HPN | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KYGDevice, Irrigation, Ocular Surgery
- JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
- DKZEnzyme Immunoassay, Amphetamine
- LDJEnzyme Immunoassay, Cannabinoids
- DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
- DJGEnzyme Immunoassay, Opiates
- LAFGas Chromatography, Methamphetamine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- HPNMagnet, Permanent
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- CEPRadioimmunoassay, Luteinizing Hormone
- KHEReagent, Occult Blood
- HNHRing, Ophthalmic (Flieringa)
- HKXTonometer, Ac-Powered
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain