510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994419Substantially Equivalent

Fastpack Psa Immunoassay, Fastpack System

Qualisys Diagnostics, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994419 is the FDA 510(k) clearance record for FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM, a class II device, cleared for Qualisys Diagnostics, Inc. on under FDA product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers). FDA records list 2 510(k) clearances for Qualisys Diagnostics, Inc., from to . As of , FDA records show 2 recalls naming K994419.

Clearance record

Decision date
Received
(182 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
Qualisys Diagnostics, Inc. 2042 Corte Del Nogal, Carlsbad CA
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