Medical Device Manufacturer · US , Beverly , MA

W.H.P.M., Inc.

14 submissions · 14 cleared · Since 2001

14

Total

14

Cleared

0

Denied

W.H.P.M., Inc. — FDA 510(k) Submissions

W.H.P.M., Inc. has submitted 14 FDA 510(k) premarket notifications since 2001, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzyme Immunoassay, Methadone, Visual, Pregnancy Hcg, Prescription Use, Enzyme Immunoassay, Amphetamine, Reagent, Occult Blood, Kit, Test, Pregnancy, Hcg, Over The Counter . Use the specialty filter in the sidebar to narrow results.

14 devices

1–14 of 14

Hemosure Accu-Reader A100

K200754 · OOX Automated Occult Blood... · Hematology

First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card, First Sign Multi-Drug Screen Test Cup

K210327 · QBF Test, Propoxyphene, Over... · Toxicology

First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of Abuse Dip Card Test Marijuana, First Sign Drug of Abuse Cup Test Marijuana

K171695 · NFT Test, Amphetamine, Over... · Toxicology

First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)

K160793 · DJR Enzyme Immunoassay,... · Toxicology

First Sign? Drug of Abuse Buprenorphine Cup Test, First Sign? Drug of Abuse Buprenorphine Dip Card Test, First Sign? Drug of Abuse Butalbital Cup Test, First Sign? Drug of Abuse Butalbital Dip Card Test, First Sign? Drug of Abuse Morphine Cup Test, First Sign? Drug of Abuse Morphine Dip Card Test.

K152551 · DJG Enzyme Immunoassay, Opiates · Toxicology

First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test

K151441 · DJR Enzyme Immunoassay,... · Chemistry

First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test

K150162 · LAF Gas Chromatography,... · Chemistry

First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup Test

K142353 · DIO Enzyme Immunoassay,... · Toxicology

FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST

K052197 · DJR Enzyme Immunoassay,... · Toxicology

WH ACCU TEST ONE-STEP URINE/SERUM COMBO PREGNANCY TEST

K051841 · JHI Visual, Pregnancy Hcg,... · Chemistry

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST

K041202 · KHE Reagent, Occult Blood · Hematology

ONE-STEP PREGNANCY TEST

K041273 · LCX Kit, Test, Pregnancy,... · Chemistry

FIRST SIGN DRUG OF ABUSE SCREENING TEST

K032575 · DKZ Enzyme Immunoassay,... · Chemistry

WH ACCU TEST PREGNANCY TEST

K012284 · JHI Visual, Pregnancy Hcg,... · Chemistry