The following data is part of a premarket notification filed by Harleco Diagnostics with the FDA for Auto-albumin Reag For Gilford 3400e Anal.
Device ID | K761026 |
510k Number | K761026 |
Device Name: | AUTO-ALBUMIN REAG FOR GILFORD 3400E ANAL |
Classification | Bromcresol Green Dye-binding, Albumin |
Applicant | HARLECO DIAGNOSTICS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CIX |
CFR Regulation Number | 862.1035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1976-11-12 |
Decision Date | 1976-11-30 |