The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Oxy-swab.
| Device ID | K831673 |
| 510k Number | K831673 |
| Device Name: | OXY-SWAB |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-05-23 |
| Decision Date | 1983-06-30 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OXY-SWAB 73329887 1230727 Dead/Cancelled |
Austin Biological Laboratories, Inc. 1981-09-28 |