The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Drvvt Screen & Hemosil Drvvt Confirm.
| Device ID | K110031 |
| 510k Number | K110031 |
| Device Name: | HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM |
| Classification | Reagent, Russel Viper Venom |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Jacqueline Emery |
| Correspondent | Jacqueline Emery INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | GIR |
| CFR Regulation Number | 864.8950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-05 |
| Decision Date | 2011-08-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950513711 | K110031 | 000 |
| 08426950513704 | K110031 | 000 |