Cleared Traditional

STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR

K880467 · Stanbio Laboratory · Chemistry
Mar 1988
Decision
50d
Days
Class 1
Risk

About This 510(k) Submission

K880467 is an FDA 510(k) clearance for the STANBIO CAB TOTAL IRON PROCEDURE, LIQUICOLOR, a Photometric Method, Iron (non-heme) (Class I — General Controls, product code JIY), submitted by Stanbio Laboratory (San Antonio, US). The FDA issued a Cleared decision on March 24, 1988, 50 days after receiving the submission on February 3, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1410.

Submission Details

510(k) Number K880467 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1988
Decision Date March 24, 1988
Days to Decision 50 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JIY — Photometric Method, Iron (non-heme)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1410

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