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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 K915708
Device Name INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SET
Applicant
TECH INTL. CO.
1856 STARR-BATT DR.
ROCHESTER HILLS,  MI  48309
Applicant Contact CHEN
Correspondent
TECH INTL. CO.
1856 STARR-BATT DR.
ROCHESTER HILLS,  MI  48309
Correspondent Contact CHEN
Regulation Number862.1580
Classification Product Code
CEO  
Date Received11/29/1991
Decision Date 01/22/1992
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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