510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K823186Substantially Equivalent

Estrocept Stabilized Estrogen Receptor

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

K823186 is the FDA 510(k) clearance record for ESTROCEPT STABILIZED ESTROGEN RECEPTOR, a class I device, cleared for Brl on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list one 510(k) clearance for Brl. As of , FDA records show no recalls naming K823186.

Clearance record

Decision date
Received
(73 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Brl 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

FDA records show no clearances under product code JJX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJX, 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