510(k) K943239
K943239 is an FDA 510(k) premarket notification submitted by Sun Biomedical Laboratories, Inc. for the device "VISUALINE II HCG". The FDA issued a decision of Substantially Equivalent on December 7, 1994. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Sun Biomedical Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 7, 1994
- Date Received
- July 6, 1994
- 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