The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Psa, Model # Elecsys 1010.
Device ID | K982948 |
510k Number | K982948 |
Device Name: | ELECSYS PSA, MODEL # ELECSYS 1010 |
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 |