The following data is part of a premarket notification filed by American Sterilizer Co. with the FDA for Biological/chemical Indicator Proof Flash.
| Device ID | K850144 |
| 510k Number | K850144 |
| Device Name: | BIOLOGICAL/CHEMICAL INDICATOR PROOF FLASH |
| Classification | Indicator, Biological Sterilization Process |
| Applicant | AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Contact | James A Spallina |
| Correspondent | James A Spallina AMERICAN STERILIZER CO. 2424 WEST 23RD ST. P.O. BOX 620 Erie, PA 16514 |
| Product Code | FRC |
| CFR Regulation Number | 880.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-14 |
| Decision Date | 1985-06-17 |