The following data is part of a premarket notification filed by Ncs Diagnostics, Inc. with the FDA for Kultsure Starswab(m240), Modification.
| Device ID | K943499 |
| 510k Number | K943499 |
| Device Name: | KULTSURE STARSWAB(M240), MODIFICATION |
| Classification | Culture Media, Non-propagating Transport |
| Applicant | NCS DIAGNOSTICS, INC. 50 STEINWAY BLVD. Etobicoke, Ontario, CA M9w 6y3 |
| Contact | Mehdi Karamchi |
| Correspondent | Mehdi Karamchi NCS DIAGNOSTICS, INC. 50 STEINWAY BLVD. Etobicoke, Ontario, CA M9w 6y3 |
| Product Code | JSM |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-13 |
| Decision Date | 1994-11-30 |