EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)

Assay, Erythropoietin

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Epo-trac(tm) 125i Radioimmunoassay (ria).

Pre-market Notification Details

Device IDK902639
510k NumberK902639
Device Name:EPO-TRAC(TM) 125I RADIOIMMUNOASSAY (RIA)
ClassificationAssay, Erythropoietin
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactDavid H Short
CorrespondentDavid H Short
INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeGGT  
CFR Regulation Number864.7250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-06-14
Decision Date1990-08-22

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