The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Psa Assay.
| Device ID | K964351 |
| 510k Number | K964351 |
| Device Name: | ELECSYS PSA ASSAY |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Contact | Mary Koning |
| Correspondent | Mary Koning BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-01 |
| Decision Date | 1997-07-25 |
| Summary: | summary |