Cleared Traditional

K992845 - HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT
(FDA 510(k) Clearance)

K992845 · Elan Holdings, Inc. · Chemistry

Oct 1999

Decision

55d

Days

Class 2

Risk

K992845 is an FDA 510(k) clearance for the HICHEM CALIBRATOR 1 KIT, HICHEM CALIBRATOR 2 KIT, HICHEM CALIBRATOR 3 KIT, CALIBRATION STANDARDS KIT, a Calibrator, Multi-analyte Mixture (Class II — Special Controls, product code JIX), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on October 18, 1999, 55 days after receiving the submission on August 24, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K992845 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 1999
Decision Date	October 18, 1999
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF