DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM

Multi-analyte Controls, All Kinds (assayed)

THERMO-ELECTRON CORP.

The following data is part of a premarket notification filed by Thermo-electron Corp. with the FDA for Data-trol N Normal Control Serum, Data-trol A Abnormal Control Serum.

Pre-market Notification Details

Device IDK052056
510k NumberK052056
Device Name:DATA-TROL N NORMAL CONTROL SERUM, DATA-TROL A ABNORMAL CONTROL SERUM
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant THERMO-ELECTRON CORP. 189-199 BROWNS RD. Noble Park, Victoria,  AU 3174
ContactMelita Lambiris
CorrespondentMelita Lambiris
THERMO-ELECTRON CORP. 189-199 BROWNS RD. Noble Park, Victoria,  AU 3174
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-29
Decision Date2005-09-23

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