The following data is part of a premarket notification filed by Hamilton Thorne Research with the FDA for Automarqer.
Device ID | K012805 |
510k Number | K012805 |
Device Name: | AUTOMARQER |
Classification | Semen Analysis Device |
Applicant | HAMILTON THORNE RESEARCH 100 CUMMINGS CENTER SUITE 102-C Beverly, MA 01915 |
Contact | Diarmaid Douglas-hamiton |
Correspondent | Diarmaid Douglas-hamiton HAMILTON THORNE RESEARCH 100 CUMMINGS CENTER SUITE 102-C Beverly, MA 01915 |
Product Code | POV |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-21 |
Decision Date | 2002-03-13 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AUTOMARQER 75543811 not registered Dead/Abandoned |
Hamilton Thorne Research Associates 1998-08-27 |