The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Status Ds Nicotine, Accusign Nicotine, Biosign Nicotine.
Device ID | K062565 |
510k Number | K062565 |
Device Name: | STATUS DS NICOTINE, ACCUSIGN NICOTINE, BIOSIGN NICOTINE |
Classification | Enzyme Immunoassay, Nicotine And Nicotine Metabolites |
Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
Contact | Kyung-ah Kim |
Correspondent | Kyung-ah Kim PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
Product Code | MKU |
CFR Regulation Number | 862.3220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-08-31 |
Decision Date | 2007-02-20 |
Summary: | summary |