N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)

Radioimmunoassay, Parathyroid Hormone

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for N-tact Pth By Immunoradiometric Assay (irma).

Pre-market Notification Details

Device IDK874299
510k NumberK874299
Device Name:N-TACT PTH BY IMMUNORADIOMETRIC ASSAY (IRMA)
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
ContactLisa J Stone
CorrespondentLisa J Stone
INCSTAR CORP. 1990 INSUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082 -0285
Product CodeCEW  
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-10-20
Decision Date1987-11-23

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