STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090— 510(k) K020138

Name: FDA 510(k) clearance K020138
Creator: U.S. Food and Drug Administration
Published: 2002-02-11

Substantially Equivalent

Gds Technology

FDA 510(k) clearance K020138 for STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090, Substantially Equivalent on 2002-02-11. Applicant: Gds Technology. Device class: 2.

Clearance details

Applicant: Gds Technology
Product code: Code KHG
Device class: Class 2
Regulation: 21 CFR 864.7500
Advisory panel: Hematology
Date received: 2002-01-16
Decision date: 2002-02-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkhart, IN, US

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