The following data is part of a premarket notification filed by Ncs Diagnostics, Inc. with the FDA for Kultsure (catalogue No. M210).
| Device ID | K860656 |
| 510k Number | K860656 |
| Device Name: | KULTSURE (CATALOGUE NO. M210) |
| Classification | Culture Media, Non-propagating Transport |
| 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 | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-21 |
| Decision Date | 1986-03-04 |