The following data is part of a premarket notification filed by Instrumentation Laboratory with the FDA for Hemosil D-dimer Hs 500 Control.
| Device ID | K133582 |
| 510k Number | K133582 |
| Device Name: | HEMOSIL D-DIMER HS 500 CONTROL |
| Classification | Plasma, Coagulation Control |
| Applicant | INSTRUMENTATION LABORATORY 180 HARTWELL RD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY 180 HARTWELL RD Bedford, MA 01730 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-21 |
| Decision Date | 2014-08-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426951024032 | K133582 | 000 |
| 08426950584933 | K133582 | 000 |