510(k) K962818
K962818 is an FDA 510(k) premarket notification submitted by Dade Intl., Inc. for the device "TOBRAMYCIN FLEX REAGENT CARTRIDGE". The FDA issued a decision of Substantially Equivalent on Sep 13, 1996. The device falls under product code LCR (Fluorescent Immunoassay, Tobramycin), a Class II device regulated under 21 CFR 862.3900. Dade Intl., Inc. has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 13, 1996
- Date Received
- Jul 19, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Fluorescent Immunoassay, Tobramycin
- Device Class
- Class II
- Regulation Number
- 862.3900
- Review Panel
- TX
- Submission Type
- 510(k)