The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Coamatic Lr Antithrombin, Note: Lr=liquid Reagents.
| Device ID | K022550 |
| 510k Number | K022550 |
| Device Name: | COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS |
| Classification | Antithrombin Iii Quantitation |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | JBQ |
| CFR Regulation Number | 864.7060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-02 |
| Decision Date | 2002-08-27 |
| Summary: | summary |