FDA 510(k) Application Details - K961249

Device Classification Name Gas Chromatography, Methamphetamine

  More FDA Info for this Device
510(K) Number K961249
Device Name Gas Chromatography, Methamphetamine
Applicant PRINCETON BIOMEDITECH CORP.
4242 U.S. ROUTE 1
P.O. BOX 7139
MONMOUTH JUNCTION, NJ 08852-1905 US
Other 510(k) Applications for this Company
Contact JEMO KANG
Other 510(k) Applications for this Contact
Regulation Number 862.3610

  More FDA Info for this Regulation Number
Classification Product Code LAF
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 04/01/1996
Decision Date 04/25/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee TX - Clinical Toxicology
Review Advisory Committee TX - Clinical Toxicology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact