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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Acid, Lactic, Enzymatic Method
510(k) Number K971944
Device Name LACTEST I
Applicant
Jwt, Inc.
115 Research Dr.
Bethlehem,  PA  18015
Applicant Contact JAMES B JOHNSTON
Correspondent
Jwt, Inc.
115 Research Dr.
Bethlehem,  PA  18015
Correspondent Contact JAMES B JOHNSTON
Regulation Number862.1450
Classification Product Code
KHP  
Date Received05/27/1997
Decision Date 12/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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