Cleared Traditional

K033060 - CALIBRATING MATERIAL, CALIBRATING STANDARDS
(FDA 510(k) Clearance)

K033060 · Diamond Diagnostics, Inc. · Chemistry

Mar 2004

Decision

157d

Days

Class 2

Risk

K033060 is an FDA 510(k) clearance for the CALIBRATING MATERIAL, CALIBRATING STANDARDS. This device is classified as a Calibrator, Secondary (Class II — Special Controls, product code JIT).

Submitted by Diamond Diagnostics, Inc. (Holliston, US). The FDA issued a Cleared decision on March 4, 2004, 157 days after receiving the submission on September 29, 2003.

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

Submission Details

510(k) Number	K033060 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2003
Decision Date	March 04, 2004
Days to Decision	157 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF