The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Ati Disposable Biological Test Pack.
| Device ID | K855120 |
| 510k Number | K855120 |
| Device Name: | ATI DISPOSABLE BIOLOGICAL TEST PACK |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
| Contact | Cleary |
| Correspondent | Cleary PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-06-18 |