The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Inr Validate, Hemosil Isi Calibrate, Isiweb (software).
| Device ID | K090563 |
| 510k Number | K090563 |
| Device Name: | HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) |
| Classification | Plasma, Coagulation Control |
| Applicant | INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg, NY 10962 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 526 RT. 303 Orangeburg, NY 10962 |
| Product Code | GGN |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JQP |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-02 |
| Decision Date | 2009-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950485629 | K090563 | 000 |
| 08426950485612 | K090563 | 000 |