The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il Test Liquid Antithrombin.
| Device ID | K994238 |
| 510k Number | K994238 |
| Device Name: | IL TEST LIQUID ANTITHROMBIN |
| Classification | Antithrombin Iii Quantitation |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-16 |
| Decision Date | 2000-06-23 |
| Summary: | summary |