510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162378Substantially Equivalent

FREND PSA PLUS (reagent cartridge)

Nanoentek USA, Inc., Pleasanton CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162378 is the FDA 510(k) clearance record for FREND PSA PLUS (reagent cartridge), a class II device, cleared for Nanoentek USA, Inc. on under FDA product code LTJ (Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers). FDA records list 5 510(k) clearances for Nanoentek USA, Inc., from to . As of , FDA records show no recalls naming K162378.

Clearance record

Decision date
Received
(266 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
Nanoentek USA, Inc. 5627 Stoneridge Dr. Suite 304, Pleasanton CA
510(k) summary
Summary PDF
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