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510(k) K981769

HICHEM PHOSPHORUS REAGENT KIT by Elan Pharma, Inc. — Product Code CEO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1998
Date Received
May 19, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Device Class
Class I
Regulation Number
862.1580
Review Panel
CH
Submission Type

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