510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K870405Substantially Equivalent

Dsl Estradial Radioimmunoassay (Dsl-4400)

Diagnostic Systems Laboratories, Inc., Webster TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870405 is the FDA 510(k) clearance record for DSL ESTRADIAL RADIOIMMUNOASSAY (DSL-4400), a class I device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code CHP (Radioimmunoassay, Estradiol). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K870405.

Clearance record

Decision date
Received
(125 days to decision)
Product code
CHP Radioimmunoassay, Estradiol
Regulation
21 CFR 862.1260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Diagnostic Systems Laboratories, Inc. 445 Medical Center Blvd., Webster TX
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