510(k) K021610
K021610 is an FDA 510(k) premarket notification submitted by Cheshire Diagnostics , Ltd. for the device "QAB2A IGM ELISA KIT HRP". The FDA issued a decision of Substantially Equivalent on July 12, 2002. 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. Cheshire Diagnostics , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 12, 2002
- Date Received
- May 16, 2002
- 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