The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil La Positive Control & Hemosil La Negative Control.
| Device ID | K113211 |
| 510k Number | K113211 |
| Device Name: | HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL |
| Classification | Plasma, Coagulation Control |
| 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 | GGN |
| Subsequent Product Code | GGC |
| Subsequent Product Code | GIZ |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-01-04 |
| Summary: | summary |