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510(k) K980180

2700 SAMPLE MANAGER by Waters Corporation — Product Code JQW

K980180 is an FDA 510(k) premarket notification submitted by Waters Corporation for the device "2700 SAMPLE MANAGER". The FDA issued a decision of Substantially Equivalent on February 12, 1998. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Waters Corporation has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1998
Date Received
January 20, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type

Other clearances by Waters Corporation

  • K063868 — MASSTRAK IMMUNOSUPPRESSANTS KIT (May 25, 2007)
  • K973074 — 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR (October 6, 1997)
  • K964588 — WATERS 515 HPLC PUMP (515) (November 29, 1996)
  • K962574 — WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) (July 22, 1996)
  • K961557 — ALLIANCE 2690 SEPARATIONS MODULE (July 5, 1996)

Other clearances for product code JQW

  • K023955 — BD VIPER INSTRUMENT (June 24, 2003)
  • K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (April 30, 1998)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K970616 — MINI SAMPLER PROCESSOR (April 21, 1997)
  • K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (March 28, 1997)
  • K962859 — MINI SAMPLE PROCESSOR (October 29, 1996)
  • K961896 — MICROLAB 4000, MICROLAB 4200 (August 16, 1996)
  • K961694 — IMPACT (June 21, 1996)
  • K953345 — GENESIS (November 21, 1995)
  • K951753 — MEDTEC AUTOBLOT 2000 (October 17, 1995)

FDA data resources