510(k) K013432
K013432 is an FDA 510(k) premarket notification submitted by Immuno Concepts, Inc. for the device "IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G". The FDA issued a decision of Substantially Equivalent on November 29, 2001. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Immuno Concepts, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 2001
- Date Received
- October 15, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Anti-Dna Indirect Immunofluorescent Solid Phase
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type