Cleared Traditional

K900708 - MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR
(FDA 510(k) Clearance)

K900708 · Innotron of Oregon, Inc. · Toxicology

Apr 1990

Decision

66d

Days

Class 2

Risk

K900708 is an FDA 510(k) clearance for the MODIFIED ACCUFLUOR VANCOMYCIN REAGENT & CALIBRATOR, 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 April 19, 1990, 66 days after receiving the submission on February 12, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3950.

Submission Details

510(k) Number	K900708 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 12, 1990
Decision Date	April 19, 1990
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Toxicology (TX)
Summary	—