Hemosure Accu-Reader A100— 510(k) K200754
Substantially EquivalentW.H.P.M., Inc.
FDA 510(k) clearance K200754 for Hemosure Accu-Reader A100, Substantially Equivalent on 2022-06-02. Applicant: W.H.P.M., Inc.. Device class: 2.
Clearance details
- Applicant
- W.H.P.M., Inc.
- Product code
- Code OOX
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irwindale, CA, US
Recent devices under product code OOX
view allMore clearances from W.H.P.M., Inc.
view all- K210327 — 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
- K171695 — 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
- K160793 — First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)
- K152551 — 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.
- K151441 — First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test
Data sourced from openFDA. This site is unofficial and independent of the FDA.