510(k) K973882
K973882 is an FDA 510(k) premarket notification submitted by Theratest Laboratories, Inc. for the device "EL-B2GP1SCR". The FDA issued a decision of Substantially Equivalent on December 5, 1997. The device falls under product code MSV (System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)), a Class II device regulated under 21 CFR 866.5660. Theratest Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 1997
- Date Received
- October 14, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
- Device Class
- Class II
- Regulation Number
- 866.5660
- Review Panel
- IM
- Submission Type