SERA-TEK THYROGLOBULIN ANTIBODY TEST

Thyroglobulin, Antigen, Antiserum, Control

MILES LABORATORIES, INC.

The following data is part of a premarket notification filed by Miles Laboratories, Inc. with the FDA for Sera-tek Thyroglobulin Antibody Test.

Pre-market Notification Details

Device IDK865020
510k NumberK865020
Device Name:SERA-TEK THYROGLOBULIN ANTIBODY TEST
ClassificationThyroglobulin, Antigen, Antiserum, Control
Applicant MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart,  IN  46514
ContactJohn H Engelmann
CorrespondentJohn H Engelmann
MILES LABORATORIES, INC. 1127 MYRTLE ST. P.O. BOX 40 Elkhart,  IN  46514
Product CodeDDC  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-23
Decision Date1987-02-02

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