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 |