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 |