Cleared Traditional

K926002 - ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (FDA 510(k) Clearance)

K926002 · Alamar Biosciences Laboratory, Inc. · Microbiology device

Sep 1993

Decision

300d

Days

Class 1

Risk

K926002 is an FDA 510(k) clearance for the ALAMAR BACTERIAL IDENTIFICATION TEST PANEL. This device is classified as a Kit, Identification, Enterobacteriaceae (Class I - General Controls, product code JSS).

Submitted by Alamar Biosciences Laboratory, Inc. (Sacramento, US). The FDA issued a Cleared decision on September 23, 1993, 300 days after receiving the submission on November 27, 1992.

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

Submission Details

510(k) Number	K926002 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 27, 1992
Decision Date	September 23, 1993
Days to Decision	300 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement