510(k) K031606
K031606 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY". The FDA issued a decision of Substantially Equivalent on June 20, 2003. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2003
- Date Received
- May 22, 2003
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Rubella
- Device Class
- Class II
- Regulation Number
- 866.3510
- Review Panel
- MI
- Submission Type