510(k) K853081
K853081 is an FDA 510(k) premarket notification submitted by Advanced Medical Technology, Inc. for the device "AURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SET". The FDA issued a decision of Substantially Equivalent on Aug 13, 1985. The device falls under product code KJK (Auramine O), a Class I device regulated under 21 CFR 864.1850. Advanced Medical Technology, Inc. has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 1985
- Date Received
- Jul 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Auramine O
- Device Class
- Class I
- Regulation Number
- 864.1850
- Review Panel
- PA
- Submission Type
- 510(k) Exempt