The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Abusign(tm) Amp, Doa-amp, Accusign(tm) Amp-doa-amp, Biosign(tm) Amp, Doa-amp.
Device ID | K945610 |
510k Number | K945610 |
Device Name: | ABUSIGN(TM) AMP, DOA-AMP, ACCUSIGN(TM) AMP-DOA-AMP, BIOSIGN(TM) AMP, DOA-AMP |
Classification | Enzyme Immunoassay, Amphetamine |
Applicant | PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
Contact | Jemo Kang |
Correspondent | Jemo Kang PRINCETON BIOMEDITECH CORP. P.O. BOX 7139 Princeton, NJ 08543 |
Product Code | DKZ |
CFR Regulation Number | 862.3100 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-15 |
Decision Date | 1995-04-13 |