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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K860987
Device Name MINI-CHEM ANALYZER
Applicant
OCEAN SCIENTIFIC, INC.
7390 LINCOLN WAY
GARDEN GROVE,  CA  92641
Applicant Contact TOM LONG
Correspondent
OCEAN SCIENTIFIC, INC.
7390 LINCOLN WAY
GARDEN GROVE,  CA  92641
Correspondent Contact TOM LONG
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received03/17/1986
Decision Date 05/05/1986
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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