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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K802422
Device Name HYCEL TRIGYCERIDE II TEST
Applicant
Hycel, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hycel, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Date Received10/06/1980
Decision Date 10/06/1980
Decision SE - Postmarket Surveillance Required (SESP)
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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