Medical Device Manufacturer · US , Tucson , AZ

Advantage Diagnostics Corp.

10 submissions · 10 cleared · Since 1988
10
Total
10
Cleared
0
Denied

Advantage Diagnostics Corp. — FDA 510(k) Submissions

Advantage Diagnostics Corp. has submitted 10 FDA 510(k) premarket notifications since 1988, of which 10 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Cannabinoids, Enzyme Immunoassay, Cocaine And Cocaine Metabolites, Cannula, Surgical, General & Plastic Surgery, Enzyme Immunoassay, Opiates, Visual, Pregnancy Hcg, Prescription Use . Use the specialty filter in the sidebar to narrow results.

10 devices
1–10 of 10
ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST
K023712 · DKZ Enzyme Immunoassay,... · Toxicology
Jan 2003 88d
PEACE OF MIND HOME DRUG TEST
K013778 · MVO Kit, Test, Multiple,... · Toxicology
Feb 2002 86d
ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST
K011962 · DIO Enzyme Immunoassay,... · Toxicology
Aug 2001 48d
ADVANTAGE MARIJUANA (THC) HOME DRUG TEST
K010921 · LDJ Enzyme Immunoassay,... · Toxicology
Jun 2001 90d
ADVANTAGE THC/COCAINE TEST
K003708 · DIO Enzyme Immunoassay,... · Toxicology
Jan 2001 52d
ADVANTAGE THC TEST
K001567 · LDJ Enzyme Immunoassay,... · Toxicology
Jun 2000 31d
ADVANTAGE HCG TEST (URINE/SERUM)
K994227 · JHI Visual, Pregnancy Hcg,... · Chemistry
Feb 2000 50d
REDI-TEST OPIATES
K991883 · DJG Enzyme Immunoassay, Opiates · Toxicology
Sep 1999 105d
CANNULA, SURGICAL
K903416 · GEA Cannula, Surgical,... · General & Plastic Surgery
Nov 1990 116d
ADVANCE DIAGNOSTICS DISPOSABLE EYECUP
K881369 · LXQ Cup, Eye · Ophthalmic
May 1988 42d
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