510(k) K930689

AUTOBEAD THYROID UPTAKE by Bio-Chem Laboratory Systems, Inc. — Product Code KHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1993
Date Received
February 10, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type