The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Met/biosign Met.
Device ID | K961249 |
510k Number | K961249 |
Device Name: | ACCUSIGN MET/BIOSIGN MET |
Classification | Gas Chromatography, Methamphetamine |
Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction, NJ 08852 -1905 |
Contact | Jemo Kang |
Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. ROUTE 1 P.O. BOX 7139 Monmouth Junction, NJ 08852 -1905 |
Product Code | LAF |
CFR Regulation Number | 862.3610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-01 |
Decision Date | 1996-04-25 |