CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS

Method, Enzymatic, Glucose (urinary, Non-quantitative)

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Chemstrip 5 Ob, Chemstrip 7 And Chemstrip 10 Md Test Strips.

Pre-market Notification Details

Device IDK032437
510k NumberK032437
Device Name:CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
ClassificationMethod, Enzymatic, Glucose (urinary, Non-quantitative)
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis,  IN  46250 -0457
ContactJennifer Tribbett
CorrespondentJennifer Tribbett
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. PO BX 50457 Indianapolis,  IN  46250 -0457
Product CodeJIL  
Subsequent Product CodeCDM
Subsequent Product CodeCEN
Subsequent Product CodeJIN
Subsequent Product CodeJIO
Subsequent Product CodeJIR
Subsequent Product CodeJJB
Subsequent Product CodeJMT
Subsequent Product CodeJRE
Subsequent Product CodeLJX
CFR Regulation Number862.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-07
Decision Date2003-10-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00075537671603 K032437 000
00075537313121 K032437 000
00075537018934 K032437 000

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