The following data is part of a premarket notification filed by Biochem Immunosystems (u.s.), Inc. with the FDA for Biodata Testosterone Maia Kit.
| Device ID | K955102 |
| 510k Number | K955102 |
| Device Name: | BIODATA TESTOSTERONE MAIA KIT |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Contact | Laurence A Potter |
| Correspondent | Laurence A Potter BIOCHEM IMMUNOSYSTEMS (U.S.), INC. 100 CASCADE DR. Allentown, PA 18103 -9562 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-08 |
| Decision Date | 1996-06-24 |
| Summary: | summary |