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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K971060
Device Name PRECINORM TDM CONTROLS
Applicant
Boehringer Mannheim Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524
Applicant Contact Yvette Lloyd
Correspondent
Boehringer Mannheim Corp.
2400 Bisso Ln.
P.O. Box 4117
Concord,  CA  94524
Correspondent Contact Yvette Lloyd
Regulation Number862.3280
Classification Product Code
DIF  
Date Received03/24/1997
Decision Date 07/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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