510(k) K043385
K043385 is an FDA 510(k) premarket notification submitted by Genzyme Diagnostics for the device "OSOM HCG COMBO TEST". The FDA issued a decision of Substantially Equivalent on April 12, 2005. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Genzyme Diagnostics has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 12, 2005
- Date Received
- December 9, 2004
- 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