The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Immunodiffusion Test Human Antithrombin.
| Device ID | K831961 |
| 510k Number | K831961 |
| Device Name: | IMMUNODIFFUSION TEST HUMAN ANTITHROMBIN |
| Classification | Antithrombin Iii Quantitation |
| Applicant | KENT LABORATORIES, INC. 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 | 1983-06-17 |
| Decision Date | 1983-08-11 |