The following data is part of a premarket notification filed by Ocean Scientific, Inc. with the FDA for Immuno-wash Automated Tube Washer.
| Device ID | K893810 |
| 510k Number | K893810 |
| Device Name: | IMMUNO-WASH AUTOMATED TUBE WASHER |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | OCEAN SCIENTIFIC, INC. 7390 LINCOLN WAY Garden Grove, CA 92641 |
| Contact | Michael Gendreau |
| Correspondent | Michael Gendreau OCEAN SCIENTIFIC, INC. 7390 LINCOLN WAY Garden Grove, CA 92641 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-22 |
| Decision Date | 1989-08-03 |