510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K910249Substantially Equivalent

Stratus Estradiol Fluoremetric Enzyme

Baxter Healthcare Corporation, Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910249 is the FDA 510(k) clearance record for STRATUS ESTRADIOL FLUOREMETRIC ENZYME, a class I device, cleared for Baxter Healthcare Corp on under FDA product code CHP (Radioimmunoassay, Estradiol). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K910249.

Clearance record

Decision date
Received
(22 days to decision)
Product code
CHP Radioimmunoassay, Estradiol
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Baxter Healthcare Corp P.O.Box 520672, Miami FL
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 November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CHP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260