The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Progesterone Assay.
| Device ID | K964841 |
| 510k Number | K964841 |
| Device Name: | ELECSYS PROGESTERONE ASSAY |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Mary Kening |
| Correspondent | Mary Kening BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-03 |
| Decision Date | 1997-03-24 |
| Summary: | summary |