INDIKO
Analyzer, Chemistry (photometric, Discrete), For Clinical Use
THERMO FISHER SCIENTIFIC OY
The following data is part of a premarket notification filed by Thermo Fisher Scientific Oy with the FDA for Indiko.
Pre-market Notification Details
| Device ID | K110035 |
| 510k Number | K110035 |
| Device Name: | INDIKO |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | THERMO FISHER SCIENTIFIC OY RATASTIE 2 Vantaa, FI 01620 |
| Contact | Paivi Sormunen |
| Correspondent | Paivi Sormunen THERMO FISHER SCIENTIFIC OY RATASTIE 2 Vantaa, FI 01620 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-05 |
| Decision Date | 2011-06-28 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16438153817793 | K110035 | 000 |
| 06438153001164 | K110035 | 000 |
| 06438153001157 | K110035 | 000 |
Trademark Results [INDIKO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 INDIKO 79087216 3922318 Live/Registered |
Thermo Fisher Scientific Oy 2010-06-09 |
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