VARELISA SM ANTIBODIES

Anti-sm Antibody, Antigen And Control

PHARMACIA & UPJOHN CO.

The following data is part of a premarket notification filed by Pharmacia & Upjohn Co. with the FDA for Varelisa Sm Antibodies.

Pre-market Notification Details

Device IDK000312
510k NumberK000312
Device Name:VARELISA SM ANTIBODIES
ClassificationAnti-sm Antibody, Antigen And Control
Applicant PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle,  OH  43082
ContactKaren Matis
CorrespondentKaren Matis
PHARMACIA & UPJOHN CO. 5094 ST. ANDREWS DR. Westervillle,  OH  43082
Product CodeLKP  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-01
Decision Date2000-03-17

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