Cleared Traditional

2700 SAMPLE MANAGER

K980180 · Waters Corporation · Toxicology
Feb 1998
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K980180 is an FDA 510(k) clearance for the 2700 SAMPLE MANAGER, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Waters Corporation (Milford, US). The FDA issued a Cleared decision on February 12, 1998, 23 days after receiving the submission on January 20, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K980180 FDA.gov
FDA Decision Cleared SESE
Date Received January 20, 1998
Decision Date February 12, 1998
Days to Decision 23 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2750

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