Medical Device Manufacturer · US , San Diego , CA

Phamatech, Inc.

15 submissions · 15 cleared · Since 2001
15
Total
15
Cleared
0
Denied

Phamatech, Inc. — FDA 510(k) Submissions

Phamatech, Inc. has submitted 15 FDA 510(k) premarket notifications since 2001, of which 15 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Opiates, Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, Radioimmunoassay, Follicle-stimulating Hormone, Enzyme Immunoassay, Barbiturate, Enzyme Immunoassay, Amphetamine . Use the specialty filter in the sidebar to narrow results.

15 devices
1–15 of 15
QuickScreen Pro Multi Drug Screening Test, Model 9395Z
K181945 · DKZ Enzyme Immunoassay,... · Toxicology
Oct 2018 90d
QUICKSCREEN AMPHETINE 500 TEST
K131069 · DKZ Enzyme Immunoassay,... · Toxicology
May 2014 392d
QUICKSCREEN COCAINE 150 SCREENING TEST
K103295 · DIO Enzyme Immunoassay,... · Toxicology
Feb 2012 450d
AT HOME DRUG TEST MODELS, 9308T AND 9308X
K070009 · DIS Enzyme Immunoassay,... · Toxicology
Dec 2007 338d
QUICKSCREEN BARBITURATE 300 SCREENING TEST, MODELS 9019, 9018; MULTI DRUG SCREENING TEST, MODEL 9317T; CUP MULTI DRUG SC
K070098 · DIS Enzyme Immunoassay,... · Toxicology
Dec 2007 331d
MOMENTS MENOPAUSE CHECK, MODEL 9113
K043599 · CGJ Radioimmunoassay,... · Chemistry
Feb 2005 58d
QUICKSCREEN OXYCODONE TEST, MODELS 9120, 9120T, 9120X AND 9121
K043051 · DJG Enzyme Immunoassay, Opiates · Chemistry
Feb 2005 95d
PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X
K043167 · JXM Enzyme Immunoassay,... · Chemistry
Dec 2004 43d
PHARMATECH MENOPAUSE CHECK, MODELS 9111 AND 9112
K040575 · CGJ Radioimmunoassay,... · Chemistry
May 2004 77d
AT HOME OVULATION TEST, MODEL 9032
K021409 · CEP Radioimmunoassay,... · Chemistry
May 2002 21d
AT HOME DRUG TEST, MODEL 9084
K013407 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 2001 52d
AT HOME DRUG TEST, MODEL 9079
K013408 · DJG Enzyme Immunoassay, Opiates · Toxicology
Dec 2001 52d
AT HOME DRUG TEST, MODEL 9074
K013409 · MVO Kit, Test, Multiple,... · Toxicology
Dec 2001 52d
AT HOME DRUG TEST, MODEL 9064
K013410 · MVO Kit, Test, Multiple,... · Toxicology
Dec 2001 52d
AT HOME DRUG TEST, MODEL 9069
K013412 · MVO Kit, Test, Multiple,... · Toxicology
Dec 2001 52d
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