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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipase-Esterase, Enzymatic, Photometric, Lipase
510(k) Number K921249
Device Name WAKO AUTOKIT LIPASE-COLOR
Applicant
Wako Chemicals USA, Inc.
1600 Bellwood Rd.
Richmond,  VA  23237
Applicant Contact ED ZIOR
Correspondent
Wako Chemicals USA, Inc.
1600 Bellwood Rd.
Richmond,  VA  23237
Correspondent Contact ED ZIOR
Regulation Number862.1465
Classification Product Code
CHI  
Date Received03/16/1992
Decision Date 07/21/1992
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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