FDA 510(k) Application Details - K970580

Device Classification Name	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile   More FDA Info for this Device
510(K) Number	K970580
Device Name	Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Applicant	SUBSTANCE ABUSE SPECIALTIES, INC. P.O.BOX 14587 RESEARCH TRIANGLE PARK, NC 27709-4587 US Other 510(k) Applications for this Company
Contact	LIBBY HAMILTON Other 510(k) Applications for this Contact
Regulation Number	864.3250   More FDA Info for this Regulation Number
Classification Product Code	KDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/14/1997
Decision Date	04/17/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	PA - Pathology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review