Acro HCG Pregnancy Rapid Test— 510(k) K180771
Substantially EquivalentAcro Biotech, Inc.
FDA 510(k) clearance K180771 for Acro HCG Pregnancy Rapid Test, Substantially Equivalent on 2018-05-18. Applicant: Acro Biotech, Inc.. Device class: 2.
Clearance details
- Applicant
- Acro Biotech, Inc.
- Product code
- Product code LCX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1155
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rancho Cucamonga, CA, US
Recent devices under product code LCX
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More clearances from Acro Biotech, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.