510(k) K932419
K932419 is an FDA 510(k) premarket notification submitted by Helix Diagnostics, Inc. for the device "ANTI-SS-B/LA ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on August 5, 1993. The device falls under product code LLL (Extractable Antinuclear Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. Helix Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 5, 1993
- Date Received
- May 18, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Extractable Antinuclear Antibody, Antigen And Control
- Device Class
- Class II
- Regulation Number
- 866.5100
- Review Panel
- IM
- Submission Type