Cleared Traditional

SLT MICROPLATE WASHER

K910740 · Tecan U.S., Ltd. · Chemistry
Mar 1991
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K910740 is an FDA 510(k) clearance for the SLT MICROPLATE WASHER, a Colorimeter, Photometer, Spectrophotometer For Clinical Use (Class I — General Controls, product code JJQ), submitted by Tecan U.S., Ltd. (Hillsborough, US). The FDA issued a Cleared decision on March 27, 1991, 34 days after receiving the submission on February 21, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2300.

Submission Details

510(k) Number K910740 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1991
Decision Date March 27, 1991
Days to Decision 34 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2300

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