510(k) K981237
K981237 is an FDA 510(k) premarket notification submitted by Inova Diagnostics, Inc. for the device "QUANTA LITE RIBOSOME P ELISA". The FDA issued a decision of Substantially Equivalent on June 5, 1998. The device falls under product code MQA (Anti-Ribosomal P Antibodies), a Class II device regulated under 21 CFR 866.5100. Inova Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 5, 1998
- Date Received
- April 3, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Ribosomal P Antibodies
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type