The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Oxystrip.
| Device ID | K930693 |
| 510k Number | K930693 |
| Device Name: | OXYSTRIP |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Contact | Melissa M Traylor |
| Correspondent | Melissa M Traylor HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria, CA 93455 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-10 |
| Decision Date | 1993-05-12 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() OXYSTRIP 78562933 not registered Dead/Abandoned |
Strippable Coatings LLC 2005-02-08 |
![]() OXYSTRIP 72459099 1005098 Dead/Expired |
OXY METAL INDUSTRIES CORPORATION 1973-06-01 |