The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil Hit-ab(pf4-h), Hemosil Hit-ab(pf4-h) Controls.
| Device ID | K153137 |
| 510k Number | K153137 |
| Device Name: | HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) 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 | 2015-10-30 |
| Decision Date | 2016-07-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950975397 | K153137 | 000 |
| 08426950975380 | K153137 | 000 |