FDA 510(k) Application Details - K971944

Device Classification Name	Acid, Lactic, Enzymatic Method   More FDA Info for this Device
510(K) Number	K971944
Device Name	Acid, Lactic, Enzymatic Method
Applicant	JWT, INC. 115 RESEARCH DR. BETHLEHEM, PA 18015 US Other 510(k) Applications for this Company
Contact	JAMES B JOHNSTON Other 510(k) Applications for this Contact
Regulation Number	862.1450   More FDA Info for this Regulation Number
Classification Product Code	KHP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/1997
Decision Date	12/17/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review