The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Stain, Hemastain Retic.
Device ID | K790042 |
510k Number | K790042 |
Device Name: | STAIN, HEMASTAIN RETIC |
Classification | Stain, Reticulocyte |
Applicant | GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GJH |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-05 |
Decision Date | 1979-02-15 |