The following data is part of a premarket notification filed by Medtronic Hemotec, Inc. with the FDA for Platelet Function Test Assay Cartridges For The Hepcon Hms.
Device ID | K954202 |
510k Number | K954202 |
Device Name: | PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS |
Classification | System, Multipurpose For In Vitro Coagulation Studies |
Applicant | MEDTRONIC HEMOTEC, INC. 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
Contact | Adrian Wilson |
Correspondent | Adrian Wilson MEDTRONIC HEMOTEC, INC. 18501 EAST PLAZA DR. Parker, CO 80134 -9061 |
Product Code | JPA |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-09-07 |
Decision Date | 1996-06-20 |
Summary: | summary |