510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820048Substantially Equivalent

Fsh Radioimmunoassay Test System

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

K820048 is the FDA 510(k) clearance record for FSH RADIOIMMUNOASSAY TEST SYSTEM, a class I device, cleared for Monobind on under FDA product code CGJ (Radioimmunoassay, Follicle-Stimulating Hormone). FDA records list 23 510(k) clearances for Monobind, from to . As of , FDA records show no recalls naming K820048.

Clearance record

Decision date
Received
(27 days to decision)
Product code
CGJ Radioimmunoassay, Follicle-Stimulating Hormone
Regulation
21 CFR 862.1300
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Monobind 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CGJ

Trailing 12 months

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

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