The following data is part of a premarket notification filed by Nanoen Tek Usa, Inc. with the FDA for Frend Tsh (reagent Cartridge).
| Device ID | K131928 |
| 510k Number | K131928 |
| Device Name: | FREND TSH (REAGENT CARTRIDGE) |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | NANOEN TEK USA, INC. 1 JACKS' HILL ROAD, STE 1 (A&B) Oxford, CT 06478 |
| Contact | Judith E Loebel |
| Correspondent | Judith E Loebel NANOEN TEK USA, INC. 1 JACKS' HILL ROAD, STE 1 (A&B) Oxford, CT 06478 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2014-03-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809317540016 | K131928 | 000 |