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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name phosphomolybdate (colorimetric), inorganic phosphorus
510(k) Number K890773
Device Name HI CHEM INORGANIC PHOSPHORUS REAGENT KIT #88196
Applicant
HICHEM DIAGNOSTICS
231 N. PUENTE ST.
BREA,  CA  92621
Applicant Contact RALPH BOLSTAD
Correspondent
HICHEM DIAGNOSTICS
231 N. PUENTE ST.
BREA,  CA  92621
Correspondent Contact RALPH BOLSTAD
Regulation Number862.1580
Classification Product Code
CEO  
Date Received02/15/1989
Decision Date 04/18/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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