Bio-Tek Automated Microplate Washer Model EL403
by Bio-Tek Instruments, Inc. 510(k)
Active
510(k) K884125
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884125 | Date2 Dec 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
-
- Terminated Z-0703-05
When software was updated for the Washer program of the Bio Tek Automated Microplate Washer Model ELx50, the software did not automatically clear old versions of the wash program when new ones were added.
Specification
- 510(k) Number
- FDA Product Code
- JTC
- Device Class
- Class I
- Regulation
- 21 CFR Part 866.2500
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent