510(k) K024151
K024151 is an FDA 510(k) premarket notification submitted by Theratest Laboratories, Inc. for the device "EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P". The FDA issued a decision of Substantially Equivalent on February 6, 2003. The device falls under product code MQA (Anti-Ribosomal P Antibodies), a Class II device regulated under 21 CFR 866.5100. Theratest Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2003
- Date Received
- December 6, 2002
- 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