The following data is part of a premarket notification filed by Quantimetrix Corp. with the FDA for Quantimetrix Bromeresol Purple Albumin.
Device ID | K830934 |
510k Number | K830934 |
Device Name: | QUANTIMETRIX BROMERESOL PURPLE ALBUMIN |
Classification | Bromcresol Purple Dye-binding, Albumin |
Applicant | QUANTIMETRIX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | CJW |
CFR Regulation Number | 862.1035 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-03-23 |
Decision Date | 1983-04-18 |