The following data is part of a premarket notification filed by Ncs Diagnostics, Inc. with the FDA for Strepslide.
| Device ID | K882811 |
| 510k Number | K882811 |
| Device Name: | STREPSLIDE |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | NCS DIAGNOSTICS, INC. 130 MATHESON BLVD. E. Mississauga, L4z 1y6, CA |
| Contact | Allen Chan |
| Correspondent | Allen Chan NCS DIAGNOSTICS, INC. 130 MATHESON BLVD. E. Mississauga, L4z 1y6, CA |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-07-07 |
| Decision Date | 1988-10-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() STREPSLIDE 73581873 1431646 Dead/Cancelled |
NCS DIAGNOSTICS INC. 1986-02-07 |