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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hydrazone Colorimetry, Alt/Sgpt
510(k) Number K864082
Device Name REFLOTRON(R) ALT (GPT)
Applicant
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact CHERI EMMONS
Correspondent
Boehringer Mannheim Corp.
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact CHERI EMMONS
Regulation Number862.1030
Classification Product Code
CKD  
Date Received10/20/1986
Decision Date 12/04/1986
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
Recalls CDRH Recalls
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