Cleared Traditional

INNOFLUOR VANCOMYCIN REAGENT SET

K872579 · Innotron of Oregon, Inc. · Chemistry
Aug 1987
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K872579 is an FDA 510(k) clearance for the INNOFLUOR VANCOMYCIN REAGENT SET, a Radioimmunoassay, Vancomycin (Class II — Special Controls, product code LEH), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on August 17, 1987, 48 days after receiving the submission on June 30, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number K872579 FDA.gov
FDA Decision Cleared SESE
Date Received June 30, 1987
Decision Date August 17, 1987
Days to Decision 48 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LEH — Radioimmunoassay, Vancomycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3950

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