510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K973243Substantially Equivalent

Active Psa Elisa (Dsl-10-9700)

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

K973243 is the FDA 510(k) clearance record for ACTIVE PSA ELISA (DSL-10-9700), a class II device, cleared for Diagnostic Systems Laboratories, Inc. on under FDA product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers). FDA records list 94 510(k) clearances for Diagnostic Systems Laboratories, Inc., from to . As of , FDA records show no recalls naming K973243.

Clearance record

Decision date
Received
(339 days to decision)
Product code
LTJ Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
Diagnostic Systems Laboratories, Inc. 445 Medical Center Blvd., Webster TX
510(k) summary
Summary
Third party review
No

Clearances, product code LTJ

Trailing 12 months
1 clearance under product code LTJ in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LTJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260