The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Il System 810, Acl And The Reagent Sets.
| Device ID | K862301 |
| 510k Number | K862301 |
| Device Name: | IL SYSTEM 810, ACL AND THE REAGENT SETS |
| Classification | Test, Thrombin Time |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
| Contact | George A Lyna |
| Correspondent | George A Lyna INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. P.O. BOX 9113 Lexington, MA 02173 |
| Product Code | GJA |
| CFR Regulation Number | 864.7875 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-17 |
| Decision Date | 1986-09-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950058366 | K862301 | 000 |
| 08426950452836 | K862301 | 000 |