Medical Device Manufacturer · US , Beverly , MA

W.H.P.M., Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2001

Recent clearances: Hemosure Accu-Reader A100, 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, 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

Total

Cleared

Denied

W.H.P.M., Inc. has 14 FDA 510(k) cleared medical devices. Based in Beverly, US.

Last cleared in 2022. Active since 2001. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by W.H.P.M., Inc. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Lsi Consulting and Smith Associates.

W.H.P.M., Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - W.H.P.M., Inc.

14 devices

1-12 of 14

Cleared Jun 02, 2022

Hemosure Accu-Reader A100

K200754 · OOX

Hematology · 801d

Cleared Aug 12, 2021

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

K210327 · QBF

Toxicology · 189d

Cleared Feb 05, 2018

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

K171695 · NFT

Toxicology · 243d

Cleared Aug 17, 2016

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

K160793 · DJR

Toxicology · 147d

Cleared Nov 09, 2015

First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse...

K152551 · DJG

Toxicology · 62d

Cleared Jun 29, 2015

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

K151441 · DJR

Chemistry · 31d

Cleared Feb 26, 2015

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

K150162 · LAF

Chemistry · 31d

Cleared Oct 07, 2014

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

K142353 · DIO

Toxicology · 47d

Cleared Jun 09, 2006

FIRST SIGN DRUG OF ABUSE URINE SCREENING TEST

K052197 · DJR

Toxicology · 301d

Cleared Aug 22, 2005

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

K051841 · JHI

Chemistry · 46d

Cleared Aug 12, 2004

HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST

K041202 · KHE

Hematology · 97d

Cleared May 20, 2004

ONE-STEP PREGNANCY TEST

K041273 · LCX

Chemistry · 8d

W.H.P.M., Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - W.H.P.M., Inc.

Filters