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 |