The following data is part of a premarket notification filed by American Diagnostic Corp. with the FDA for Actichrome Atiii Kit.
| Device ID | K893608 |
| 510k Number | K893608 |
| Device Name: | ACTICHROME ATIII KIT |
| Classification | Antithrombin Iii Quantitation |
| Applicant | AMERICAN DIAGNOSTIC CORP. 49 EAST 68TH ST. New York, NY 10021 |
| Contact | Richard Hart |
| Correspondent | Richard Hart AMERICAN DIAGNOSTIC CORP. 49 EAST 68TH ST. New York, NY 10021 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-05-10 |
| Decision Date | 1989-06-23 |