Cleared Traditional

API 20E/UNISCEPT 20E

K924814 · Analytical Products, Inc. · Microbiology
Mar 1993
Decision
167d
Days
Class 1
Risk

About This 510(k) Submission

K924814 is an FDA 510(k) clearance for the API 20E/UNISCEPT 20E, a Kit, Identification, Enterobacteriaceae (Class I — General Controls, product code JSS), submitted by Analytical Products, Inc. (Plainview, US). The FDA issued a Cleared decision on March 11, 1993, 167 days after receiving the submission on September 25, 1992. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K924814 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 1992
Decision Date March 11, 1993
Days to Decision 167 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code JSS — Kit, Identification, Enterobacteriaceae
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660