The following data is part of a premarket notification filed by Andwin Scientific with the FDA for Safetex Combination Blood (alcohol, Ethyl) / Urine Collection And Transport Kit.
| Device ID | K964698 |
| 510k Number | K964698 |
| Device Name: | SAFETEX COMBINATION BLOOD (ALCOHOL, ETHYL) / URINE COLLECTION AND TRANSPORT KIT |
| Classification | Tubes, Vials, Systems, Serum Separators, Blood Collection |
| Applicant | ANDWIN SCIENTIFIC 1219 EAST BRIDLETRAIL RD. Draper, UT 84020 -8523 |
| Contact | A. Thomas Doyle |
| Correspondent | A. Thomas Doyle ANDWIN SCIENTIFIC 1219 EAST BRIDLETRAIL RD. Draper, UT 84020 -8523 |
| Product Code | JKA |
| Subsequent Product Code | GJE |
| Subsequent Product Code | LYY |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-22 |
| Decision Date | 1997-03-03 |