510(k) K960367
K960367 is an FDA 510(k) premarket notification submitted by Incstar Corp. for the device "INCSTAR RUBELLA IGG ELISA ASSAY". The FDA issued a decision of Substantially Equivalent on October 24, 1996. The device falls under product code LFX (Enzyme Linked Immunoabsorbent Assay, Rubella), a Class II device regulated under 21 CFR 866.3510. Incstar Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 1996
- Date Received
- January 25, 1996
- 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