BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
FDA 510(k) clearance K884125 · decided 1988-12-02
Clearance details
- K-number
- K884125
- Device name
- BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
- Applicant
- Bio-Tek Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-09-30
- Decision date
- 1988-12-02
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- JTC
- Device class
- 1
- Regulation number
- 866.2500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Winooski, VT, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| GENETIC SYSTEMS MICROPLATE WASHER (K891768) | Genetic Systems Corp. | 1989-05-01 |
| GENETIC SYSTEMS MICROPLATE STRIP WASHER (K891766) | Genetic Systems Corp. | 1989-05-01 |
| GENETIC SYSTEMS PIPETTOR/DILUTOR (K891765) | Genetic Systems Corp. | 1989-05-01 |
| WASHER 500 MICROELISA SYSTEM (K884695) | Organon Teknika Corp. | 1988-12-13 |
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| MICROPLATE AUTO-WASHER (MOTORIZED STAGE) (K873542) | Genetic Systems Corp. | 1987-09-23 |
| MICROLAB AT (K871945) | Hamilton Co. | 1987-05-29 |
| CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 (K863423) | Plastic Injectors, Inc. | 1986-09-16 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Version 7 Software for wash program on Bio Tek Automated Microplate Washer Model ELx50 whi recall (Z-0703-05) | Diasorin Inc. | 2005-04-13 |