ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10

Calibrator, Secondary

DENKA SEIKEN CO., LTD.

The following data is part of a premarket notification filed by Denka Seiken Co., Ltd. with the FDA for Archiect Insulin And Controls, Model 8k41-01, 8k41-10.

Pre-market Notification Details

Device IDK060359
510k NumberK060359
Device Name:ARCHIECT INSULIN AND CONTROLS, MODEL 8K41-01, 8K41-10
ClassificationCalibrator, Secondary
Applicant DENKA SEIKEN CO., LTD. 1-2-2, MINAMI HON CHO Gosen-shi, Niigata,  JP 959-1695
ContactToshimi Matsunaga
CorrespondentToshimi Matsunaga
DENKA SEIKEN CO., LTD. 1-2-2, MINAMI HON CHO Gosen-shi, Niigata,  JP 959-1695
Product CodeJIT  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-02-13
Decision Date2006-04-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740017545 K060359 000
00380740017521 K060359 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.