The following data is part of a premarket notification filed by Vickers America Medical Corp. with the FDA for Hemacheck.
| Device ID | K781562 |
| 510k Number | K781562 |
| Device Name: | HEMACHECK |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | VICKERS AMERICA MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-11 |
| Decision Date | 1978-11-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEMACHECK 73226256 1180913 Dead/Cancelled |
Vickers America Medical Corporation 1979-08-06 |
![]() HEMACHECK 72462431 0994511 Dead/Expired |
MILES LABORATORIES, INC. 1973-07-09 |