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510(k) K000375

RANDOX CALCIUM by Randox Laboratories, Ltd. — Product Code CIC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2000
Date Received
February 7, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cresolphthalein Complexone, Calcium
Device Class
Class II
Regulation Number
862.1145
Review Panel
CH
Submission Type

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