The following data is part of a premarket notification filed by Waters Corporation with the FDA for 2700 Sample Manager.
Device ID | K980180 |
510k Number | K980180 |
Device Name: | 2700 SAMPLE MANAGER |
Classification | Station, Pipetting And Diluting, For Clinical Use |
Applicant | WATERS CORPORATION 34 MAPLE ST. Milford, MA 01757 -3696 |
Contact | Virginia L Corbin |
Correspondent | Virginia L Corbin WATERS CORPORATION 34 MAPLE ST. Milford, MA 01757 -3696 |
Product Code | JQW |
CFR Regulation Number | 862.2750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-20 |
Decision Date | 1998-02-12 |