Cleared Traditional

ROBOTIC SAMPLE PROCESSOR

K894126 · Tecan U.S., Ltd. · Chemistry
Aug 1989
Decision
64d
Days
Class 1
Risk

About This 510(k) Submission

K894126 is an FDA 510(k) clearance for the ROBOTIC SAMPLE PROCESSOR, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Tecan U.S., Ltd. (Hillsborough, US). The FDA issued a Cleared decision on August 15, 1989, 64 days after receiving the submission on June 12, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K894126 FDA.gov
FDA Decision Cleared SESE
Date Received June 12, 1989
Decision Date August 15, 1989
Days to Decision 64 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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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