510(k) K833841
K833841 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST IGG IGA & IGM KITS". The FDA issued a decision of Substantially Equivalent on January 4, 1984. The device falls under product code CZK (Iga, Rhodamine, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Instrumentation Laboratory CO has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 4, 1984
- Date Received
- November 7, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Iga, Rhodamine, Antigen, Antiserum, Control
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type