THROMBO TEK PSE, MODEL 90-480

Test, Qualitative And Quantitative Factor Deficiency

R2 DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by R2 Diagnostics, Inc. with the FDA for Thrombo Tek Pse, Model 90-480.

Pre-market Notification Details

Device IDK082631
510k NumberK082631
Device Name:THROMBO TEK PSE, MODEL 90-480
ClassificationTest, Qualitative And Quantitative Factor Deficiency
Applicant R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend,  IN  46628
ContactMarc D Goldford
CorrespondentMarc D Goldford
R2 DIAGNOSTICS, INC. 1801 COMMERCE DR. South Bend,  IN  46628
Product CodeGGP  
CFR Regulation Number864.7290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-10
Decision Date2008-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00859394006095 K082631 000

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