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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 K870776
Device Name RAICHEM(TM) PHOSPHORUS REAGENT, RAPID ENDPOINT
Applicant
REAGENTS APPLICATIONS, INC.
8225 MERCURY CT.
SAN DIEGO,  CA  92111 -1203
Applicant Contact ALFRED E PEACOCK,JR
Correspondent
REAGENTS APPLICATIONS, INC.
8225 MERCURY CT.
SAN DIEGO,  CA  92111 -1203
Correspondent Contact ALFRED E PEACOCK,JR
Regulation Number862.1580
Classification Product Code
CEO  
Date Received02/26/1987
Decision Date 03/13/1987
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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