510(k) K893577
K893577 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "STATUS HCG FLUOROMETRIC ENZYME". The FDA issued a decision of Substantially Equivalent on Aug 3, 1989. The device falls under product code DHA (System, Test, Human Chorionic Gonadotropin), a Class II device regulated under 21 CFR 862.1155. Baxter Healthcare Corp has 507 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 3, 1989
- Date Received
- May 9, 1989
- 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
- 510(k)