Medical Device Manufacturer · US , Lake Forest , CA

Accu-Stat Diagnostics, Inc.

3 submissions · 3 cleared · Since 2004
3
Total
3
Cleared
0
Denied

Accu-Stat Diagnostics, Inc. — FDA 510(k) Submissions

Accu-Stat Diagnostics, Inc. has submitted 3 FDA 510(k) premarket notifications since 2004, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Cannabinoids, Kit, Test, Multiple, Drugs Of Abuse, Over The Counter . Use the specialty filter in the sidebar to narrow results.

3 devices
1–3 of 3
ACCU-STAT HOME DRUG TEST CUP FOR MAIJUANNA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MAMP), ECSTASY
K041221 · LDJ Enzyme Immunoassay,... · Toxicology
Jul 2004 64d
ACCU-STAT HOME DRUG TEST FOR MARIJUANA, COCAINE, AMPHETAMINE, METHAMPHETAMINE, OPIATES, AND PHENCYCLIDINE
K040629 · LDJ Enzyme Immunoassay,... · Toxicology
May 2004 56d
ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)
K040327 · MVO Kit, Test, Multiple,... · Toxicology
Apr 2004 69d
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