Clearance Summary
BLUE DOT(TM) TEST FOR PREGNANCY received FDA 510(k) clearance under submission number K882588, sponsored by V-Tech, 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 1988-10-06.
- Submission: K882588
- Applicant / Sponsor: V-Tech, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1155
- Decision date: 1988-10-06
Classification & Regulation
This clearance is catalogued under FDA product code LCX and 21 CFR 862.1155, within the Clinical Chemistry review panel as a Class II device.