510(k) K832031
K832031 is an FDA 510(k) premarket notification submitted by Breit Laboratories, Inc. for the device "ANTI-N DNA ANTIBODY TEST KIT". The FDA issued a decision of Substantially Equivalent on August 11, 1983. The device falls under product code KTL (Anti-Dna Indirect Immunofluorescent Solid Phase), a Class II device regulated under 21 CFR 866.5100. Breit Laboratories, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1983
- Date Received
- June 23, 1983
- 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