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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, Triglycerides
510(k) Number K780825
Device Name TRIGLYCERIDE C-37 RAPID STAT KIT
Applicant
Pierce Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pierce Chemical Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1705
Classification Product Code
JGY  
Date Received05/19/1978
Decision Date 05/26/1978
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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