FDA.reportPublic FDA data

510(k) K031698

Device
ELECYS SHBG CALCHECK
Applicant
Roche Diagnostics Corp.
510(k) number
K031698
Product code
JJX
Decision
Substantially Equivalent (SESE)
Decision date
2003-08-20
Date received
2003-06-02
Regulation
862.1660
Classification name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
THERESA A AMBROSE
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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