INCSTAR ACTH IRMA

Radioimmunoassay, Acth

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Acth Irma.

Pre-market Notification Details

Device IDK940271
510k NumberK940271
Device Name:INCSTAR ACTH IRMA
ClassificationRadioimmunoassay, Acth
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactMary Ellen Best
CorrespondentMary Ellen Best
INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeCKG  
CFR Regulation Number862.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-01-21
Decision Date1994-08-02

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