The following data is part of a premarket notification filed by Qualigen, Inc. with the FDA for Fastpack Ip Sex Hormone Binding Globulin Immunoassay.
| Device ID | K182521 |
| 510k Number | K182521 |
| Device Name: | FastPack IP Sex Hormone Binding Globulin Immunoassay |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92011 |
| Contact | Wajdi Abdul-ahad |
| Correspondent | Wajdi Abdul-ahad Qualigen, Inc. 2042 Corte Del Nogal Carlsbad, CA 92011 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-13 |
| Decision Date | 2019-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816467020345 | K182521 | 000 |