The following data is part of a premarket notification filed by Starplex Scientific, Inc. with the FDA for Starswab Culture Collection And Transport System.
| Device ID | K960997 |
| 510k Number | K960997 |
| Device Name: | STARSWAB CULTURE COLLECTION AND TRANSPORT SYSTEM |
| Classification | Device, Specimen Collection |
| 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 | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-12 |
| Decision Date | 1996-04-03 |
| Summary: | summary |