510(k) K862248
K862248 is an FDA 510(k) premarket notification submitted by Windsor Laboratories, Inc. for the device "AMIKACIN KIT (FPIA)". The FDA issued a decision of Substantially Equivalent on August 4, 1986. The device falls under product code LGJ (Fluorescence Polarization Immunoassay, Amibacin), a Class II device regulated under 21 CFR 862.3035. Windsor Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 4, 1986
- Date Received
- June 12, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorescence Polarization Immunoassay, Amibacin
- Device Class
- Class II
- Regulation Number
- 862.3035
- Review Panel
- TX
- Submission Type