510(k) K771487
K771487 is an FDA 510(k) premarket notification submitted by Ortho Diagnostics, Inc. for the device "LEWIS BLOOD GROUP SUBSTANCE". The FDA issued a decision of Substantially Equivalent on November 8, 1977. The device falls under product code KSX (Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use), a Class II device regulated under 21 CFR 864.9160. Ortho Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 8, 1977
- Date Received
- August 5, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
- Device Class
- Class II
- Regulation Number
- 864.9160
- Review Panel
- HE
- Submission Type