Cleared Traditional

K862560 - PRECEPT CEFTIZOXIME
(FDA 510(k) Clearance)

K862560 · Austin Biological Laboratories · Microbiology
Jul 1986
Decision
8d
Days
Class 2
Risk

K862560 is an FDA 510(k) clearance for the PRECEPT CEFTIZOXIME. This device is classified as a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY).

Submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on July 11, 1986, 8 days after receiving the submission on July 3, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K862560 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1986
Decision Date July 11, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code JWY — Manual Antimicrobial Susceptibility Test Systems
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.1640

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