The following data is part of a premarket notification filed by Starplex Scientific, Inc. with the FDA for Kultsure/starswab Anaerobic Transport System.
| Device ID | K944847 |
| 510k Number | K944847 |
| Device Name: | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM |
| Classification | Culture Media, Anaerobic Transport |
| Applicant | STARPLEX SCIENTIFIC, INC. 50 STEINWAY BLVD. UNIT #5 Etobicoke, Ontario, CA M9w 6y3 |
| Contact | Mehdi Karamchi |
| Correspondent | Mehdi Karamchi STARPLEX SCIENTIFIC, INC. 50 STEINWAY BLVD. UNIT #5 Etobicoke, Ontario, CA M9w 6y3 |
| Product Code | JSL |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-30 |
| Decision Date | 1995-02-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00819398026321 | K944847 | 000 |