Cleared Traditional

EMDS ALBUMIN (ALB) TEST

K935179 · Em Diagnostic Systems, Inc. · Chemistry
Dec 1993
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K935179 is an FDA 510(k) clearance for the EMDS ALBUMIN (ALB) TEST, a Bromcresol Green Dye-binding, Albumin (Class II — Special Controls, product code CIX), submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 17, 1993, 52 days after receiving the submission on October 26, 1993. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K935179 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 1993
Decision Date December 17, 1993
Days to Decision 52 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CIX — Bromcresol Green Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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