ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)

System, Automated Platelet Aggregation

ACCUMETRICS, INC.

The following data is part of a premarket notification filed by Accumetrics, Inc. with the FDA for Ultegra System Rapid Platelet Function Assay - Asa (rpfa-asa).

Pre-market Notification Details

Device IDK012701
510k NumberK012701
Device Name:ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
ClassificationSystem, Automated Platelet Aggregation
Applicant ACCUMETRICS, INC. 3985 SORRENTO VALLEY BLVD. San Diego,  CA  92121
ContactRhonda Moe
CorrespondentRhonda Moe
ACCUMETRICS, INC. 3985 SORRENTO VALLEY BLVD. San Diego,  CA  92121
Product CodeJOZ  
CFR Regulation Number864.5700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-08-14
Decision Date2002-06-12
Summary:summary

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