ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS

Catalytic Methods, Amylase

ROCHE DIAGNOSTIC SYSTEMS, INC.

The following data is part of a premarket notification filed by Roche Diagnostic Systems, Inc. with the FDA for Roche Cobas Integra Reagent Cassettes & Ancillary Reagents.

Pre-market Notification Details

Device IDK972250
510k NumberK972250
Device Name:ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS
ClassificationCatalytic Methods, Amylase
Applicant ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
ContactMaria Feijoo
CorrespondentMaria Feijoo
ROCHE DIAGNOSTIC SYSTEMS, INC. BRANCHBURG TOWNSHIP 1080 U.S. HIGHWAY 202 Somerville,  NJ  08876 -3771
Product CodeJFJ  
Subsequent Product CodeCDQ
Subsequent Product CodeCDT
Subsequent Product CodeCET
Subsequent Product CodeCFR
Subsequent Product CodeCGX
Subsequent Product CodeCHH
Subsequent Product CodeDLB
Subsequent Product CodeDLJ
Subsequent Product CodeJIF
Subsequent Product CodeJQB
Subsequent Product CodeLAS
Subsequent Product CodeLFM
CFR Regulation Number862.1070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-16
Decision Date1997-08-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336164891 K972250 000
04015630914708 K972250 000
04015630926985 K972250 000
04015630927005 K972250 000
04015630928071 K972250 000
04015630924875 K972250 000
04015630926886 K972250 000
04015630916511 K972250 000
07613336121009 K972250 000
07613336121016 K972250 000
07613336121603 K972250 000
04015630918935 K972250 000

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