Hemosure Accu-Reader A100
K-Number: K200754 · 2022-06-02
ApplicantW.H.P.M., Inc.
Decision Date2022-06-02
Product CodeOOX
Advisory CommitteeHE
DecisionSubstantially Equivalent
Device Summary
Hemosure Accu-Reader A100 is a medical device manufactured by W.H.P.M., Inc.. It received FDA 510(k) clearance on 2022-06-02 under approval number K200754. The device is classified under product code OOX. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hemosure Accu-Reader A100?
Hemosure Accu-Reader A100 is a medical device that received FDA 510(k) clearance on 2022-06-02. It is manufactured by W.H.P.M., Inc.. The 510(k) number is K200754.
When was Hemosure Accu-Reader A100 approved by the FDA?
Hemosure Accu-Reader A100 received FDA 510(k) clearance on 2022-06-02, under approval number K200754.
What company makes Hemosure Accu-Reader A100?
Hemosure Accu-Reader A100 is manufactured by W.H.P.M., Inc..
What is the FDA product code for Hemosure Accu-Reader A100?
The FDA product code for Hemosure Accu-Reader A100 is OOX.
Other Devices by W.H.P.M., Inc.
K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
K171695First 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
K210327First 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
Related Devices (Code: OOX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.