The following data is part of a premarket notification filed by Coulter Electronics, Inc. with the FDA for Hc Plus.
Device ID | K833563 |
510k Number | K833563 |
Device Name: | HC PLUS |
Classification | Mixture, Hematology Quality Control |
Applicant | COULTER ELECTRONICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JPK |
CFR Regulation Number | 864.8625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-12 |
Decision Date | 1984-01-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() HC PLUS 76540514 2892869 Dead/Cancelled |
Central Reserve Life Insurance Company 2003-08-27 |