The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Accusign Amp 300, Biosign Amp 300, Status Ds Amp 300, Syva Rapid Test D.a.u..
Device ID | K001225 |
510k Number | K001225 |
Device Name: | ACCUSIGN AMP 300, BIOSIGN AMP 300, STATUS DS AMP 300, SYVA RAPID TEST D.A.U. |
Classification | Enzyme Immunoassay, Amphetamine |
Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
Contact | Jemo Kang |
Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
Product Code | DKZ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-04-17 |
Decision Date | 2000-05-17 |