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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Phosphoric-Tungstic (Spectrophotometric), Chloride
510(k) Number K934588
Device Name CHLORIDE (MF) ASSAY
Applicant
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals , Ltd.
West Royalty Industrial Park,
Charlottetown, P.E.I.,  CA C1E 2A6
Correspondent Contact KAREN CALLBECK
Regulation Number862.1170
Classification Product Code
CHG  
Date Received09/23/1993
Decision Date 02/18/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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