The following data is part of a premarket notification filed by Medical Laboratory Automation Systems, Inc. with the FDA for Tytem(r) Reagent Dispenser.
| Device ID | K871687 |
| 510k Number | K871687 |
| Device Name: | TYTEM(R) REAGENT DISPENSER |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Contact | Joann Hanchrow |
| Correspondent | Joann Hanchrow MEDICAL LABORATORY AUTOMATION SYSTEMS, INC. 270 MARBLE AVE. Pleasantville, NY 10570 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-29 |
| Decision Date | 1987-05-20 |