The following data is part of a premarket notification filed by Chromogenix Ab with the FDA for Coacute Antithrombin R Chromogenic Assay.
| Device ID | K952515 |
| 510k Number | K952515 |
| Device Name: | COACUTE ANTITHROMBIN R CHROMOGENIC ASSAY |
| Classification | Antithrombin Iii Quantitation |
| Applicant | CHROMOGENIX AB 160 INDUSTRIAL DR. Franklin, OH 45005 |
| Contact | Cynthia A Ipach |
| Correspondent | Cynthia A Ipach CHROMOGENIX AB 160 INDUSTRIAL DR. Franklin, OH 45005 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-31 |
| Decision Date | 1996-01-23 |