Medical Device Manufacturer · US , Miami , FL

Ameritek, Inc.

17 submissions · 17 cleared · Since 1986
17
Total
17
Cleared
0
Denied

Ameritek, Inc. — FDA 510(k) Submissions

Ameritek, Inc. has submitted 17 FDA 510(k) premarket notifications since 1986, of which 17 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Amphetamine, Visual, Pregnancy Hcg, Prescription Use, Enzyme Immunoassay, Cannabinoids, Gas Chromatography, Methamphetamine, Enzyme Immunoassay, Opiates . Use the specialty filter in the sidebar to narrow results.

17 devices
1–17 of 17
DBEST HCG 2 IU/ML TEST KIT
K001215 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jun 2000 69d
DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE
K990873 · JMT Diazo (colorimetric),... · Chemistry
Sep 1999 169d
DBSET MULTIDRUG SCREEN TEST KIT
K990681 · DKZ Enzyme Immunoassay,... · Toxicology
Jul 1999 135d
DBEST OCCULT BLOOD TEST KIT
K984269 · KHE Reagent, Occult Blood · Hematology
May 1999 201d
DBEST TETRAHYDROCANNABINOL TEST KIT
K983188 · LDJ Enzyme Immunoassay,... · Toxicology
Nov 1998 68d
DBEST METHAMPHETAMINES TEST KIT
K983189 · LAF Gas Chromatography,... · Toxicology
Nov 1998 68d
DBEST OPIATES TEST KIT
K983190 · DJG Enzyme Immunoassay, Opiates · Toxicology
Nov 1998 68d
DBEST COCAINE TEST KIT
K983191 · DIO Enzyme Immunoassay,... · Toxicology
Nov 1998 68d
DBEST AMPHETAMINES TEST KIT
K981504 · DKZ Enzyme Immunoassay,... · Toxicology
Aug 1998 101d
DBEST ONE-STEP OVULATION TEST
K974508 · CEP Radioimmunoassay,... · Chemistry
Feb 1998 63d
DBEST ONE-STEP HCG SERUM/URINE TEST
K973957 · JHI Visual, Pregnancy Hcg,... · Chemistry
Dec 1997 62d
DBEST REAGENT STRIP FOR URINALYSIS
K973142 · JIL Method, Enzymatic,... · Chemistry
Oct 1997 60d
BEST PREGNANCY TEST
K953606 · LCX Kit, Test, Pregnancy,... · Chemistry
Mar 1996 233d
RK VACUUM FIXATION RING SYSTEM
K863775 · HNH Ring, Ophthalmic (flieringa) · Ophthalmic
Oct 1986 24d
SURGICAL IOP MONITOR
K863235 · HKX Tonometer, Ac-powered · Ophthalmic
Sep 1986 35d
RARE EARTH INTRA-OCULAR MAGNET
K860960 · HPN Magnet, Permanent · Ophthalmic
Mar 1986 18d
ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)
K861013 · KYG Device, Irrigation,... · Ophthalmic
Mar 1986 13d
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