510(k) K920008
K920008 is an FDA 510(k) premarket notification submitted by Instrumentation Laboratory CO for the device "IL TEST IMMUNOGLOBULIN M (IGM)". The FDA issued a decision of Substantially Equivalent on March 11, 1992. The device falls under product code CGM (Method, Immunodiffusion, Immunoglobulins (G, A, M)), 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
- March 11, 1992
- Date Received
- January 2, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Method, Immunodiffusion, Immunoglobulins (G, A, M)
- Device Class
- Class II
- Regulation Number
- 866.5510
- Review Panel
- IM
- Submission Type