510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K830934Substantially Equivalent

Quantimetrix Bromeresol Purple Albumin

Quantimetrix Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830934 is the FDA 510(k) clearance record for QUANTIMETRIX BROMERESOL PURPLE ALBUMIN, a class II device, cleared for Quantimetrix Corp. on under FDA product code CJW (Bromcresol Purple Dye-Binding, Albumin). FDA records list 39 510(k) clearances for Quantimetrix Corp., from to . As of , FDA records show no recalls naming K830934.

Clearance record

Decision date
Received
(26 days to decision)
Product code
CJW Bromcresol Purple Dye-Binding, Albumin
Regulation
21 CFR 862.1035
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Quantimetrix Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CJW

Trailing 12 months

FDA records hold no clearances under product code CJW in the trailing twelve months.

FDA records show no clearances under product code CJW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CJW, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260