The following data is part of a premarket notification filed by Waters Corporation with the FDA for 2487 Dual Wavelength Absorbance Detector.
Device ID | K973074 |
510k Number | K973074 |
Device Name: | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR |
Classification | Chromatography (liquid, Gel), 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 | KZR |
CFR Regulation Number | 862.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-18 |
Decision Date | 1997-10-06 |