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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 K873638
Device Name MICRO-CHEM ANALYZER
Applicant
Ocean Scientific, Inc.
7390 Lincoln Way
Garden Grove,  CA  92641
Applicant Contact ANDREW PERRY
Correspondent
Ocean Scientific, Inc.
7390 Lincoln Way
Garden Grove,  CA  92641
Correspondent Contact ANDREW PERRY
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received09/09/1987
Decision Date 09/29/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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