510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853866Substantially Equivalent

Pantex Direct Estradiol Coated Tube Radioimmunoass

Pantex, Div. Bio-Analysis, Inc., Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853866 is the FDA 510(k) clearance record for PANTEX DIRECT ESTRADIOL COATED TUBE RADIOIMMUNOASS, a class I device, cleared for Pantex, Div. Bio-Analysis, Inc. on under FDA product code CHP (Radioimmunoassay, Estradiol). FDA records list 16 510(k) clearances for Pantex, Div. Bio-Analysis, Inc., from to . As of , FDA records show no recalls naming K853866.

Clearance record

Decision date
Received
(28 days to decision)
Product code
CHP Radioimmunoassay, Estradiol
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Pantex, Div. Bio-Analysis, Inc. 1737 21st St., Santa Monica CA
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