FDA.reportPublic FDA data

510(k) K071433

Device
SMS GLUCOSE CONTROL, MODEL 2120059
Applicant
Specialty Medical Supplies
510(k) number
K071433
Product code
JJY
Decision
Substantially Equivalent (SESE)
Decision date
2007-06-28
Date received
2007-05-23
Regulation
862.1660
Classification name
Multi-Analyte Controls, All Kinds (Assayed)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN C GORMLEY
Address
940 Crossroads Blvd. Seguin TX US 78155 78155

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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