STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090

Whole Blood Hemoglobin Determination

GDS TECHNOLOGY

The following data is part of a premarket notification filed by Gds Technology with the FDA for Stat-site Mhgb Meter, Stat-site Mhgb Meter Card Holder, Stat-site Mhgb Test Cards, Stat-site Mhgb Code Way, Models 90090.

Pre-market Notification Details

Device IDK020138
510k NumberK020138
Device Name:STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
ClassificationWhole Blood Hemoglobin Determination
Applicant GDS TECHNOLOGY 25235 LEER DR. Elkhart,  IN  46514
ContactRichard Tyhach
CorrespondentRichard Tyhach
GDS TECHNOLOGY 25235 LEER DR. Elkhart,  IN  46514
Product CodeKHG  
CFR Regulation Number864.7500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-01-16
Decision Date2002-02-11

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.