The following data is part of a premarket notification filed by Diagnostica, Inc. with the FDA for Ease-a-cult.
| Device ID | K002756 |
| 510k Number | K002756 |
| Device Name: | EASE-A-CULT |
| Classification | Reagent, Occult Blood |
| Applicant | DIAGNOSTICA, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Yolanda Smith DIAGNOSTICA, INC. P.O. BOX 4341 Crofton, MD 21114 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-05 |
| Decision Date | 2001-02-23 |