510(k) K853920
K853920 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "BIO-TEK EL 401 HANDHELD MICROPLATE WASHER". The FDA issued a decision of Substantially Equivalent on October 22, 1985. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 1985
- Date Received
- September 23, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Microtiter Diluting/Dispensing
- Device Class
- Class I
- Regulation Number
- 866.2500
- Review Panel
- MI
- Submission Type