The following data is part of a premarket notification filed by Self Care Systems, Inc. with the FDA for Ez Detech-urine Blood Test Sticks.
| Device ID | K854358 |
| 510k Number | K854358 |
| Device Name: | EZ DETECH-URINE BLOOD TEST STICKS |
| Classification | Reagent, Occult Blood |
| Applicant | SELF CARE SYSTEMS, INC. 1527 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Connealy |
| Correspondent | Connealy SELF CARE SYSTEMS, INC. 1527 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | KHE |
| CFR Regulation Number | 864.6550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-29 |
| Decision Date | 1986-04-09 |