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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Amyloclastic, Amylase
510(k) Number K873520
Device Name PARAMAX AMYLASE REAGENT
Applicant
Baxter Healthcare Corp
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact KRISTA SMALLEY
Correspondent
Baxter Healthcare Corp
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact KRISTA SMALLEY
Regulation Number862.1070
Classification Product Code
CJA  
Date Received09/01/1987
Decision Date 11/23/1987
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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