510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K041349Substantially Equivalent

Luminescent Immunoassay Kit for the Detection of Estradiol in Saliva and Serum

Ibl GmbH, East Stroudsburg PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K041349 is the FDA 510(k) clearance record for LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUM, a class I device, cleared for Ibl GmbH on under FDA product code CHP (Radioimmunoassay, Estradiol). FDA records list 6 510(k) clearances for Ibl GmbH, from to . As of , FDA records show no recalls naming K041349.

Clearance record

Decision date
Received
(127 days to decision)
Product code
CHP Radioimmunoassay, Estradiol
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Ibl GmbH 150 Cherry Ln. Rd., East Stroudsburg PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CHP

Trailing 12 months

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

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