510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K894265Substantially Equivalent

Dsl 17A-Oh Progersterone (Dsl #6800)

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

K894265 is the FDA 510(k) clearance record for DSL 17A-OH PROGERSTERONE (DSL #6800), a class I device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code JLX (Radioimmunoassay, 17-Hydroxyprogesterone). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K894265.

Clearance record

Decision date
Received
(77 days to decision)
Product code
JLX Radioimmunoassay, 17-Hydroxyprogesterone
Regulation
21 CFR 862.1395
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 JLX

Trailing 12 months

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

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