Clearance Summary
CHEMTRUE HCG PREGNANCY URINE DIPSTICK, HCG PREGNANCY URINE CASSETTE TEST, AND HCG COMBO SERUM/URINE CASSETTE TEST received FDA 510(k) clearance under submission number K123844, sponsored by Chemtron Biotech, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2013-05-30.
- Submission: K123844
- Applicant / Sponsor: Chemtron Biotech, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 2013-05-30
Classification & Regulation
This clearance is catalogued under FDA product code JHI and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.