The following data is part of a premarket notification filed by Geometric Data, Div. Smithkline Corp. with the FDA for Hemastain Phosphate Buffer.
Device ID | K760487 |
510k Number | K760487 |
Device Name: | HEMASTAIN PHOSPHATE BUFFER |
Classification | Stains, Hematology |
Applicant | GEOMETRIC DATA, DIV. SMITHKLINE CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KQC |
CFR Regulation Number | 864.1850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-08-20 |
Decision Date | 1976-08-30 |