The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Abusign(tm) Thc, Doa-thc, Accusign(tm) Thc, Doa-thc, Diosign(tm) Thc, Doa-thc.
| Device ID | K945550 |
| 510k Number | K945550 |
| Device Name: | ABUSIGN(TM) THC, DOA-THC, ACCUSIGN(TM) THC, DOA-THC, DIOSIGN(TM) THC, DOA-THC |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-14 |
| Decision Date | 1995-02-22 |