510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K844679Substantially Equivalent

Dsl Pap Ria -Dsl#3100

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

K844679 is the FDA 510(k) clearance record for DSL PAP RIA -DSL#3100, a class II device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K844679.

Clearance record

Decision date
Received
(150 days to decision)
Product code
JFH Acid Phosphatase (Prostatic), Tartrate Inhibited
Regulation
21 CFR 862.1020
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Diagnostic Systems Laboratories, Inc. 445 Medical Center Blvd., Webster TX
Third party review
No

Clearances, product code JFH

Trailing 12 months

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

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