510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955647Substantially Equivalent

Vidas Estradiol II (E2ii) Assay

Biomerieux Vitek, Inc., Rockland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955647 is the FDA 510(k) clearance record for VIDAS ESTRADIOL II (E2II) ASSAY, a class I device, cleared for Biomerieux Vitek, Inc. on under FDA product code CHP (Radioimmunoassay, Estradiol). FDA records list 49 510(k) clearances for Biomerieux Vitek, Inc., from to . As of , FDA records show 2 recalls naming K955647.

Clearance record

Decision date
Received
(56 days to decision)
Product code
CHP Radioimmunoassay, Estradiol
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Biomerieux Vitek, Inc. 1022 Hingham St., Rockland MA
510(k) summary
Summary
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