510(k) K863475
K863475 is an FDA 510(k) premarket notification submitted by 3M Company for the device "THEOFAST(TM) TEST PACKAGE". The FDA issued a decision of Substantially Equivalent on November 5, 1986. The device falls under product code LER (Fluorescent Immunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1986
- Date Received
- September 9, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorescent Immunoassay, Theophylline
- Device Class
- Class II
- Regulation Number
- 862.3880
- Review Panel
- TX
- Submission Type