The following data is part of a premarket notification filed by Ncs Diagnostics, Inc. with the FDA for Kultsure.
Device ID | K870231 |
510k Number | K870231 |
Device Name: | KULTSURE |
Classification | Device, Specimen Collection |
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 | LIO |
CFR Regulation Number | 866.2900 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-01-21 |
Decision Date | 1987-02-04 |