510(k) K883235
K883235 is an FDA 510(k) premarket notification submitted by Synbiotics Corp. for the device "RAPIDTEST-HCG (TM)". The FDA issued a decision of Substantially Equivalent on September 30, 1988. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Synbiotics Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 30, 1988
- Date Received
- August 1, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Human Chorionic Gonadotropin
- Device Class
- Class II
- Regulation Number
- 862.1155
- Review Panel
- CH
- Submission Type