The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Thermo Scientific Sensititre Aris Hiq System.
| Device ID | K191914 |
| 510k Number | K191914 |
| Device Name: | Thermo Scientific Sensititre ARIS HiQ System |
| Classification | Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems |
| Applicant | Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44014 6 |
| Contact | Cynthia Knapp |
| Correspondent | Cynthia Knapp Thermo Fisher Scientific 1 Thermo Fisher Way Oakwood Village, OH 44014 6 |
| Product Code | LRG |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-17 |
| Decision Date | 2019-11-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M578V4000 | K191914 | 000 |