510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903609Substantially Equivalent

Serotonin Enzyme Immunoassay

IMMUNOTECH s.r.o., Cedex 9 (France), FR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903609 is the FDA 510(k) clearance record for SEROTONIN ENZYME IMMUNOASSAY, a class I device, cleared for Immunotech Corp. on under FDA product code CDA (Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin). FDA records list 42 510(k) clearances for IMMUNOTECH s.r.o., from to . As of , FDA records show no recalls naming K903609.

Clearance record

Decision date
Received
(74 days to decision)
Product code
CDA Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
Regulation
21 CFR 862.1390
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Immunotech Corp. 130, Ave. Jean De Lattre De, Cedex 9 (France), FR
Third party review
No

Clearances, product code CDA

Trailing 12 months

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

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