The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Psa, Model 2010.
| Device ID | K982949 |
| 510k Number | K982949 |
| Device Name: | ELECSYS PSA, MODEL 2010 |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Priscilla A Hamill |
| Correspondent | Priscilla A Hamill BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-21 |
| Decision Date | 1998-10-27 |
| Summary: | summary |