The following data is part of a premarket notification filed by Oxis Intl., Inc. with the FDA for B-l Red(tm) Discs.
| Device ID | K950346 |
| 510k Number | K950346 |
| Device Name: | B-L RED(TM) DISCS |
| Classification | Discs, Strips And Reagents, Microorganism Differentiation |
| Applicant | OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 Portland, OR 97217 -3935 |
| Contact | Lynda M Taylor |
| Correspondent | Lynda M Taylor OXIS INTL., INC. 6040 NORTH CUTTER CIR., #317 Portland, OR 97217 -3935 |
| Product Code | JTO |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-27 |
| Decision Date | 1995-05-05 |