510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964756Substantially Equivalent

Prostatic Acid Phosphatase Reagent Test/prostatic Acid Phosphatase Reagent Kit

Wano-Tech Corp., Belmont CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964756 is the FDA 510(k) clearance record for PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT, a class II device, cleared for Wano-Tech Corp. on under FDA product code JFH (Acid Phosphatase (Prostatic), Tartrate Inhibited). FDA records list one 510(k) clearance for Wano-Tech Corp. As of , FDA records show no recalls naming K964756.

Clearance record

Decision date
Received
(147 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
Wano-Tech Corp. 260 Harbor Blvd., Belmont CA
510(k) summary
Summary
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