The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Stratus Progesterone Fluorometric Enzyme Immunoassay.
| Device ID | K950570 |
| 510k Number | K950570 |
| Device Name: | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Contact | Richard D Bliss Jr. |
| Correspondent | Richard D Bliss Jr. BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami, FL 33152 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-03 |
| Decision Date | 1995-04-11 |