The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Ca 125ii On The Elecsys 1010.
Device ID | K980240 |
510k Number | K980240 |
Device Name: | ELECSYS CA 125II ON THE ELECSYS 1010 |
Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
Applicant | BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
Contact | Jody J Savage |
Correspondent | Jody J Savage BOEHRINGER MANNHEIM CORP. 4300 HACIENDA DR. Pleasanton, CA 94588 -2722 |
Product Code | LTK |
CFR Regulation Number | 866.6010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-01-23 |
Decision Date | 1998-03-25 |
Summary: | summary |