The following data is part of a premarket notification filed by Self Care Systems, Inc. with the FDA for Ez Detect, 5 Minute Strep-a Color Test.
| Device ID | K860923 |
| 510k Number | K860923 |
| Device Name: | EZ DETECT, 5 MINUTE STREP-A COLOR TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | SELF CARE SYSTEMS, INC. 1527 MONROVIA AVE. Newport Beach, CA 92663 |
| Contact | Chandravadan Patel |
| Correspondent | Chandravadan Patel SELF CARE SYSTEMS, INC. 1527 MONROVIA AVE. Newport Beach, CA 92663 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-11 |
| Decision Date | 1986-05-16 |