The following data is part of a premarket notification filed by Princeton Biomeditech Corp. with the FDA for Biosign Ifobtest, Biosign Fecal Occult Blood Test.
| Device ID | K100817 |
| 510k Number | K100817 |
| Device Name: | BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST |
| Classification | Reagent, Occult Blood |
| Applicant | PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Contact | Jemo Kang, Ph.d. |
| Correspondent | Jemo Kang, Ph.d. PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 Monmouth Junction, NJ 08852 -1905 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-19 |
| Decision Date | 2010-07-01 |