510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903359Substantially Equivalent

Microzyme Unconjugated Estriol Enzyme Immuno Kit

IMMUNOTECH s.r.o., Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903359 is the FDA 510(k) clearance record for MICROZYME UNCONJUGATED ESTRIOL ENZYME IMMUNO KIT, a class I device, cleared for Immunotech Corp. on under FDA product code CGI (Radioimmunoassay, Estriol). FDA records list 42 510(k) clearances for IMMUNOTECH s.r.o., from to . As of , FDA records show no recalls naming K903359.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CGI Radioimmunoassay, Estriol
Regulation
21 CFR 862.1265
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Immunotech Corp. 90 Windom St., Boston MA
Third party review
No

Clearances, product code CGI

Trailing 12 months

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

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