Cleared Traditional

PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT

K964756 · Wano-Tech Corp. · Chemistry

Apr 1997

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K964756 is an FDA 510(k) clearance for the PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT, a Acid Phosphatase (prostatic), Tartrate Inhibited (Class II — Special Controls, product code JFH), submitted by Wano-Tech Corp. (Belmont, US). The FDA issued a Cleared decision on April 23, 1997, 147 days after receiving the submission on November 27, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1020.

Submission Details

510(k) Number	K964756 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 27, 1996
Decision Date	April 23, 1997
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF