The following data is part of a premarket notification filed by Tri-continent Scientific, Inc. with the FDA for Modumatic (r) Diluter.
| Device ID | K861640 |
| 510k Number | K861640 |
| Device Name: | MODUMATIC (R) DILUTER |
| Classification | Station, Pipetting And Diluting, For Clinical Use |
| Applicant | TRI-CONTINENT SCIENTIFIC, INC. 12555 LOMA RICA DR., #2 Grass Valley, CA 95945 |
| Contact | Gary W Mccluskey |
| Correspondent | Gary W Mccluskey TRI-CONTINENT SCIENTIFIC, INC. 12555 LOMA RICA DR., #2 Grass Valley, CA 95945 |
| Product Code | JQW |
| CFR Regulation Number | 862.2750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-30 |
| Decision Date | 1986-05-23 |