510(k) K883940
K883940 is an FDA 510(k) premarket notification submitted by Ortho Diagnostic Systems, Inc. for the device "ORTHO* ROTAVIRUS LATEX AGGLUTINATION TEST". The FDA issued a decision of Substantially Equivalent on January 4, 1989. The device falls under product code LIQ (Enzyme Linked Immunoabsorbent Assay, Rotavirus), a Class I device regulated under 21 CFR 866.3405. Ortho Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1989
- Date Received
- September 19, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Enzyme Linked Immunoabsorbent Assay, Rotavirus
- Device Class
- Class I
- Regulation Number
- 866.3405
- Review Panel
- MI
- Submission Type