The following data is part of a premarket notification filed by Monobind Inc. with the FDA for Free Testosterone Accubind Elisa Test System.
| Device ID | K181017 |
| 510k Number | K181017 |
| Device Name: | Free Testosterone AccuBind ELISA Test System |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Monobind Inc. 100 North Pointe Drive Lake Forest, CA 92630 |
| Contact | Anthony Shatola |
| Correspondent | Anthony Shatola Monobind Inc. 100 North Pointe Drive Lake Forest, CA 92630 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-10 |
| Decision Date | 2018-07-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840239061010 | K181017 | 000 |
| 04048474061017 | K181017 | 000 |