510(k) K810081
K810081 is an FDA 510(k) premarket notification submitted by Scripps-Miles, Inc. for the device "SCRIPPSERA ANA REFERENCE CONTROL SERA". The FDA issued a decision of Substantially Equivalent on February 9, 1981. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Scripps-Miles, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1981
- Date Received
- January 13, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type