510(k) K870732
K870732 is an FDA 510(k) premarket notification submitted by Val Tech Diagnostics, Inc. for the device "RAT LIVER NUCLEI TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 10, 1987. The device falls under product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5100. Val Tech Diagnostics, Inc. has 10 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 10, 1987
- Date Received
- Feb 25, 1987
- 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
- 510(k)