Cleared Traditional

K001484 - CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838
(FDA 510(k) Clearance)

K001484 · Alko Diagnostic Corp. · Chemistry

Jun 2000

Decision

39d

Days

Class 2

Risk

K001484 is an FDA 510(k) clearance for the CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838. 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 June 19, 2000, 39 days after receiving the submission on May 11, 2000.

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

Submission Details

510(k) Number	K001484 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2000
Decision Date	June 19, 2000
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF