The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Stratus Progesterone Flourometric Immunoassay.
| Device ID | K933635 |
| 510k Number | K933635 |
| Device Name: | STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | BAXTER DIAGNOSTICS, INC. SCIENTIFIC PRODUCTS DIV. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Contact | Betty Hernandez-labadie |
| Correspondent | Betty Hernandez-labadie BAXTER DIAGNOSTICS, INC. SCIENTIFIC PRODUCTS DIV. 1430 WAUKEGAN RD. Mcgaw Park, IL 60085 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-27 |
| Decision Date | 1993-10-08 |