SLT MICROPLATE WASHER

Colorimeter, Photometer, Spectrophotometer For Clinical Use

TECAN U.S., LTD.

The following data is part of a premarket notification filed by Tecan U.s., Ltd. with the FDA for Slt Microplate Washer.

Pre-market Notification Details

Device IDK910740
510k NumberK910740
Device Name:SLT MICROPLATE WASHER
ClassificationColorimeter, Photometer, Spectrophotometer For Clinical Use
Applicant TECAN U.S., LTD. 164 DIMMOCKS MILL RD. P.O. BOX 8101 Hillsborough,  NC  27278
ContactDaniel B Roark
CorrespondentDaniel B Roark
TECAN U.S., LTD. 164 DIMMOCKS MILL RD. P.O. BOX 8101 Hillsborough,  NC  27278
Product CodeJJQ  
CFR Regulation Number862.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-21
Decision Date1991-03-27

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