The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Liquid Antithrombin.
| Device ID | K062431 |
| 510k Number | K062431 |
| Device Name: | HEMOSIL LIQUID ANTITHROMBIN |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-21 |
| Decision Date | 2006-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195226000061 | K062431 | 000 |
| 08426950440802 | K062431 | 000 |
| 08426950087571 | K062431 | 000 |
| 08426950056003 | K062431 | 000 |
| 08426950358701 | K062431 | 000 |