The following data is part of a premarket notification filed by Self Care Systems, Inc. with the FDA for Modified Ez Detect Occult Blood Test In Stool.
| Device ID | K860028 |
| 510k Number | K860028 |
| Device Name: | MODIFIED EZ DETECT OCCULT BLOOD TEST IN STOOL |
| Classification | Reagent, Occult Blood |
| Applicant | SELF CARE SYSTEMS, INC. 1527 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Leigh E Connealy,md |
| Correspondent | Leigh E Connealy,md 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 | 1986-01-03 |
| Decision Date | 1986-04-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00083059100013 | K860028 | 000 |
| 00083059010015 | K860028 | 000 |
| 08305900100013 | K860028 | 000 |
| 08305900010015 | K860028 | 000 |