Cleared Traditional

K970921 - STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)
(FDA 510(k) Clearance)

K970921 · Alko Diagnostic Corp. · Chemistry

Apr 1997

Decision

27d

Days

Class 2

Risk

K970921 is an FDA 510(k) clearance for the STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0). This device is classified as a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX).

Submitted by Alko Diagnostic Corp. (Holliston, US). The FDA issued a Cleared decision on April 8, 1997, 27 days after receiving the submission on March 12, 1997.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K970921 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 12, 1997
Decision Date	April 08, 1997
Days to Decision	27 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF