The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Hematrak Maturity Profile Option.
Device ID | K761208 |
510k Number | K761208 |
Device Name: | HEMATRAK MATURITY PROFILE OPTION |
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 | 1976-12-07 |
Decision Date | 1977-02-28 |