The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Hematrak.
Device ID | K770680 |
510k Number | K770680 |
Device Name: | HEMATRAK |
Classification | Counter, Differential Cell |
Applicant | GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-04-11 |
Decision Date | 1977-07-01 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
HEMATRAK 73005983 1029205 Dead/Expired |
GEOMETRIC DATA CORPORATION 1973-11-28 |