510(k) K003856
K003856 is an FDA 510(k) premarket notification submitted by Biomerica, Inc. for the device "EZ-HCG URINE(PREGNANCY TEST)". The FDA issued a decision of Substantially Equivalent on February 21, 2001. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Biomerica, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 21, 2001
- Date Received
- December 13, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Visual, Pregnancy Hcg, Prescription Use
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type