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 |