The following data is part of a premarket notification filed by Adi Diagnostics, Inc. with the FDA for Visuwell Group A Streptococcus Detection Kit.
| Device ID | K890840 |
| 510k Number | K890840 |
| Device Name: | VISUWELL GROUP A STREPTOCOCCUS DETECTION KIT |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| Applicant | ADI DIAGNOSTICS, INC. 30 MERIDIAN ROAD Rexdale, Ontario, CA M9w 4z7 |
| Contact | Janet Shaw |
| Correspondent | Janet Shaw ADI DIAGNOSTICS, INC. 30 MERIDIAN ROAD Rexdale, Ontario, CA M9w 4z7 |
| Product Code | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-21 |
| Decision Date | 1989-03-27 |