Medical Device Manufacturer · US , Beverly , MA

Waters Corporation - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1996

Recent clearances: 2700 SAMPLE MANAGER, 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR, WATERS 515 HPLC PUMP (515)

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Waters Corporation Toxicology ✕

6 devices

1-6 of 6

Cleared May 25, 2007

MASSTRAK IMMUNOSUPPRESSANTS KIT

Toxicology · 147d

Cleared Feb 12, 1998

2700 SAMPLE MANAGER

Toxicology · 23d

Cleared Oct 06, 1997

2487 DUAL WAVELENGTH ABSORBANCE DETECTOR

Toxicology · 49d

Cleared Nov 29, 1996

WATERS 515 HPLC PUMP (515)

Toxicology · 14d

Cleared Jul 22, 1996

WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)

Toxicology · 21d

Cleared Jul 05, 1996

ALLIANCE 2690 SEPARATIONS MODULE

Toxicology · 74d