Medical Device Manufacturer · US , San Diego , CA

Phamatech

47 submissions · 47 cleared · Since 1996
47
Total
47
Cleared
0
Denied

Phamatech — FDA 510(k) Submissions

Phamatech has submitted 47 FDA 510(k) premarket notifications since 1996, of which 47 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, Kit, Test, Pregnancy, Hcg, Over The Counter, Gas Chromatography, Methamphetamine, Enzyme Immunoassay, Amphetamine, Enzyme Immunoassay, Phencyclidine . Use the specialty filter in the sidebar to narrow results.

47 devices
1–25 of 47
QUICKSCREEN, MODELS 9177X AND 9178X
K041578 · LCM Enzyme Immunoassay,... · Chemistry
Sep 2004 88d
AT HOME DRUG CUP, MODEL 9150X
K030447 · MVO Kit, Test, Multiple,... · Toxicology
Apr 2003 62d
AT WORK DRUG TEST, MODEL 9177T AWT
K010833 · DIO Enzyme Immunoassay,... · Toxicology
Apr 2001 22d
AT WORK DRUG TEST, MODEL 9147T AWT
K010836 · LAF Gas Chromatography,... · Toxicology
Apr 2001 22d
AT HOME DRUG TEST, MODEL 9068 T
K010653 · MVO Kit, Test, Multiple,... · Toxicology
Apr 2001 31d
AT HOME DRUG TEST, MODEL 9078 T
K010654 · MVO Kit, Test, Multiple,... · Toxicology
Apr 2001 31d
AT HOME DRUG TESTT, MODEL 9150 T
K010655 · MVO Kit, Test, Multiple,... · Toxicology
Apr 2001 31d
AT HOME DRUG TEST, MODEL 9063 T
K010645 · DKZ Enzyme Immunoassay,... · Toxicology
Mar 2001 25d
AT HOME DRUG TEST, MODEL 9083 T
K010646 · MVO Kit, Test, Multiple,... · Toxicology
Mar 2001 25d
AT HOME DRUG TEST, MODEL 9073 T
K010650 · DIO Enzyme Immunoassay,... · Toxicology
Mar 2001 25d
AT HOME DRUG TEST, MODEL 9133 T
K010651 · LCM Enzyme Immunoassay,... · Toxicology
Mar 2001 25d
MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175
K003858 · MVO Kit, Test, Multiple,... · Toxicology
Feb 2001 61d
QUICKSCREEN PRO DRUG CUP, MODEL 9195X
K001397 · DKZ Enzyme Immunoassay,... · Toxicology
May 2000 23d
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
K000447 · LAF Gas Chromatography,... · Toxicology
Mar 2000 26d
QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9153 PAT04
K000131 · LDJ Enzyme Immunoassay,... · Toxicology
Feb 2000 17d
AT HOME DRUG TEST, MODEL 9073
K994219 · DIO Enzyme Immunoassay,... · Toxicology
Dec 1999 15d
AT HOME DRUG TEST, MODEL 9078
K994220 · LDJ Enzyme Immunoassay,... · Toxicology
Dec 1999 15d
AT HOME DRUG TEST, MODEL 9068
K994233 · LAF Gas Chromatography,... · Toxicology
Dec 1999 14d
AT HOME DRUG TEST, MODEL 9083
K994234 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 1999 14d
AT HOME DRUG TEST, MODEL 9133
K994236 · LCM Enzyme Immunoassay,... · Toxicology
Dec 1999 14d
AT HOME DRUG TEST, MODEL 9063
K994237 · DKZ Enzyme Immunoassay,... · Toxicology
Dec 1999 14d
AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C
K994093 · LCL Radioimmunoassay,... · Toxicology
Dec 1999 13d
AT HOME QUICKCUP PREGNANCY TEST, MODEL 9015
K993141 · LCX Kit, Test, Pregnancy,... · Chemistry
Nov 1999 48d
QUICKSCREEN PRO MULTI DRUG SCREEN, MODEL 9177 & 9178
K993165 · DJG Enzyme Immunoassay, Opiates · Toxicology
Oct 1999 28d
QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C
K992685 · MVO Kit, Test, Multiple,... · Toxicology
Oct 1999 57d
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