The following data is part of a premarket notification filed by Tecan U.s., Inc. with the FDA for 4 Channel Dispenser.
Device ID | K944556 |
510k Number | K944556 |
Device Name: | 4 CHANNEL DISPENSER |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | TECAN U.S., INC. P.O. BOX 13953 Research Triangle Park, NC 27709 |
Contact | Daniel Roark |
Correspondent | Daniel Roark TECAN U.S., INC. P.O. BOX 13953 Research Triangle Park, NC 27709 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-09-16 |
Decision Date | 1994-10-25 |