The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Blood-smearing Instrument (miniprep Tm).
Device ID | K760007 |
510k Number | K760007 |
Device Name: | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) |
Classification | Spinner, Slide, Automated |
Applicant | GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GKJ |
CFR Regulation Number | 864.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-06-08 |
Decision Date | 1976-09-03 |