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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00848838066931 | K943499 | 000 |
00848838066924 | K943499 | 000 |
00848838066917 | K943499 | 000 |
00848838066900 | K943499 | 000 |
00848838066894 | K943499 | 000 |
00848838066887 | K943499 | 000 |
00848838066856 | K943499 | 000 |