510(k) K974606

RANDOX MAGNESIUM by Randox Laboratories, Ltd. — Product Code JGJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 12, 1998
Date Received
December 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Magnesium
Device Class
Class I
Regulation Number
862.1495
Review Panel
CH
Submission Type