510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K980716Substantially Equivalent

Advantage Chemiluminescence Prostate Specific Antigen (Psa) Immunoassay

Nichols Institute Diagnostics, San Juan Capistrano CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K980716 is the FDA 510(k) clearance record for ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY, a class II device, cleared for Nichols Institute Diagnostics on under FDA product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers). FDA records list 68 510(k) clearances for Nichols Institute Diagnostics, from to . As of , FDA records show no recalls naming K980716.

Clearance record

Decision date
Received
(86 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
Nichols Institute Diagnostics 33051 Calle Aviador, San Juan Capistrano 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