Cleared Traditional

ORTHO ALT MICROWELL TEST SYSTEM

K941192 · Ortho Diagnostic Systems, Inc. · Chemistry
May 1995
Decision
428d
Days
Class 1
Risk

About This 510(k) Submission

K941192 is an FDA 510(k) clearance for the ORTHO ALT MICROWELL TEST SYSTEM, a Hydrazone Colorimetry, Alt/sgpt (Class I — General Controls, product code CKD), submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on May 16, 1995, 428 days after receiving the submission on March 14, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K941192 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 1994
Decision Date May 16, 1995
Days to Decision 428 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CKD — Hydrazone Colorimetry, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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