Cleared Special

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

K020138 · Gds Technology · Hematology

Feb 2002

Decision

26d

Days

Class 2

Risk

About This 510(k) Submission

K020138 is an FDA 510(k) clearance for the STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090, a Whole Blood Hemoglobin Determination (Class II — Special Controls, product code KHG), submitted by Gds Technology (Elkhart, US). The FDA issued a Cleared decision on February 11, 2002, 26 days after receiving the submission on January 16, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7500.

Submission Details

510(k) Number	K020138 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 16, 2002
Decision Date	February 11, 2002
Days to Decision	26 days
Submission Type	Special
Review Panel	Hematology (HE)
Summary	Statement