510(k) K902793
K902793 is an FDA 510(k) premarket notification submitted by Pharmacia Diagnostics, Inc. for the device "RUBELLA IGG". The FDA issued a decision of Substantially Equivalent on July 31, 1990. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Pharmacia Diagnostics, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 31, 1990
- Date Received
- June 26, 1990
- Clearance Type
- Traditional
- 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