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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Lecithin/Sphingomyelin Ratio
510(k) Number K883411
Device Name PG-NUMERIC(TM)
Applicant
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Applicant Contact WENDY S CLINE
Correspondent
Isolab, Inc.
Drawer 4350
Akron,  OH  44321
Correspondent Contact WENDY S CLINE
Regulation Number862.1455
Classification Product Code
JHF  
Date Received08/15/1988
Decision Date 03/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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