Cleared Traditional

K860369 - API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC
(FDA 510(k) Clearance)

K860369 · Analytical Products, Inc. · Microbiology
Mar 1986
Decision
36d
Days
Class 2
Risk

K860369 is an FDA 510(k) clearance for the API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC, a Manual Antimicrobial Susceptibility Test Systems (Class II — Special Controls, product code JWY), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on March 11, 1986, 36 days after receiving the submission on February 3, 1986. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.1640.

Submission Details

510(k) Number K860369 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1986
Decision Date March 11, 1986
Days to Decision 36 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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