The following data is part of a premarket notification filed by Andwin Scientific with the FDA for Safetex Chlamydia Trachomatis Specimen Collection Kit.
| Device ID | K983599 |
| 510k Number | K983599 |
| Device Name: | SAFETEX CHLAMYDIA TRACHOMATIS SPECIMEN COLLECTION KIT |
| Classification | Spatula, Cervical, Cytological |
| Applicant | ANDWIN SCIENTIFIC 6636 VARIEL AVE. Canoga Park, CA 91303 |
| Contact | Natalie Sarraf |
| Correspondent | Natalie Sarraf ANDWIN SCIENTIFIC 6636 VARIEL AVE. Canoga Park, CA 91303 |
| Product Code | HHT |
| CFR Regulation Number | 884.4530 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-14 |
| Decision Date | 1998-12-11 |