The following data is part of a premarket notification filed by Iline Microsystems S.l. with the FDA for Microinr System.
| Device ID | K201185 |
| 510k Number | K201185 |
| Device Name: | MicroINR System |
| Classification | Test, Time, Prothrombin |
| Applicant | iLine Microsystems S.L. Paseo Mikeletegi, 69 San Sebastian-donostia, ES 20009 |
| Contact | Miren Itaso Hormaeche |
| Correspondent | Marcia L Zucker ZIVD LLC 62 Pollard Rd Plaistow, NH 03865 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-01 |
| Decision Date | 2020-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08436540290694 | K201185 | 000 |
| 08436540290700 | K201185 | 000 |