510(k) K023947
K023947 is an FDA 510(k) premarket notification submitted by Thermo Biostar, Inc. for the device "GC OIA". The FDA issued a decision of Substantially Equivalent on April 17, 2003. The device falls under product code LIR (Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae), a Class II device regulated under 21 CFR 866.3390. Thermo Biostar, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2003
- Date Received
- November 27, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae
- Device Class
- Class II
- Regulation Number
- 866.3390
- Review Panel
- MI
- Submission Type