The following data is part of a premarket notification filed by Nanoen Tek, Inc. with the FDA for Frend Psa Plus (reagent Cartridge).
| Device ID | K124056 |
| 510k Number | K124056 |
| Device Name: | FREND PSA PLUS (REAGENT CARTRIDGE) |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | NANOEN TEK, INC. 1 JACK'S HILL RD. SUITE 1 (A&B) Oxford, CT 06478 |
| Contact | Judith E Loebel |
| Correspondent | Judith E Loebel NANOEN TEK, INC. 1 JACK'S HILL RD. SUITE 1 (A&B) Oxford, CT 06478 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-31 |
| Decision Date | 2013-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809317540184 | K124056 | 000 |
| 08809317540207 | K124056 | 000 |
| 08809317541259 | K124056 | 000 |