The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Acustar Hit-igg(pf4-h), Hemosil Acustar Hit Controls.
| Device ID | K170854 |
| 510k Number | K170854 |
| Device Name: | HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls |
| Classification | Platelet Factor 4 Radioimmunoassay |
| Applicant | Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble Instrumentation Laboratory Co. 180 Hartwell Road Bedford, MA 01730 |
| Product Code | LCO |
| CFR Regulation Number | 864.7695 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-22 |
| Decision Date | 2017-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426951126545 | K170854 | 000 |
| 08426951126538 | K170854 | 000 |