The following data is part of a premarket notification filed by Neometrics, Inc. with the FDA for Accuscreen 17-hydroxyprogesterone.
| Device ID | K934178 |
| 510k Number | K934178 |
| Device Name: | ACCUSCREEN 17-HYDROXYPROGESTERONE |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | NEOMETRICS, INC. 104 BELLEROSE AVE. East Northport, NY 11731 |
| Contact | David Schwartz |
| Correspondent | David Schwartz NEOMETRICS, INC. 104 BELLEROSE AVE. East Northport, NY 11731 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-27 |
| Decision Date | 1995-03-30 |