CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM

Indirect Copper Assay, Ceruloplasmin

TECHNICON INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Ceruloplasmin For The Technicon Dpa-1(tm) System.

Pre-market Notification Details

Device IDK882622
510k NumberK882622
Device Name:CERULOPLASMIN FOR THE TECHNICON DPA-1(TM) SYSTEM
ClassificationIndirect Copper Assay, Ceruloplasmin
Applicant TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactLeonard A Dwarica
CorrespondentLeonard A Dwarica
TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeJFR  
CFR Regulation Number866.5210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-06-24
Decision Date1988-07-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.