Cleared Traditional

K861888 - HIPPURATE HYDROLYSIS TEST
(FDA 510(k) Clearance)

K861888 · Pro-Lab, Inc. · Microbiology
Jun 1986
Decision
18d
Days
Class 1
Risk

K861888 is an FDA 510(k) clearance for the HIPPURATE HYDROLYSIS TEST. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I — General Controls, product code JTO).

Submitted by Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA). The FDA issued a Cleared decision on June 3, 1986, 18 days after receiving the submission on May 16, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K861888 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1986
Decision Date June 03, 1986
Days to Decision 18 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JTO — Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660