The following data is part of a premarket notification filed by American Dade with the FDA for Prototro/proteolytic Enzyme Control.
| Device ID | K831297 |
| 510k Number | K831297 |
| Device Name: | PROTOTRO/PROTEOLYTIC ENZYME CONTROL |
| Classification | Antithrombin Iii Quantitation |
| Applicant | AMERICAN DADE 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-21 |
| Decision Date | 1983-06-08 |