The following data is part of a premarket notification filed by Waters Corporation with the FDA for Waters 474 Scanning Flourescence Detector (474).
Device ID | K962574 |
510k Number | K962574 |
Device Name: | WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) |
Classification | Detectors, Electrochemical, Liquid Chromatography |
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 | LEQ |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-01 |
Decision Date | 1996-07-22 |