The following data is part of a premarket notification filed by Oxoid U.s.a., Inc. with the FDA for Bacillum Pumilus Spore Strips.
| Device ID | K810930 |
| 510k Number | K810930 |
| Device Name: | BACILLUM PUMILUS SPORE STRIPS |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | OXOID U.S.A., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-06 |
| Decision Date | 1981-06-16 |