Cleared Traditional

K871231 - ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B
(FDA 510(k) Clearance)

K871231 · Microscan Div. Baxter Healthcare Corp. · Microbiology

Jun 1987

Decision

91d

Days

Class 1

Risk

K871231 is an FDA 510(k) clearance for the ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B. This device is classified as a Antigens, Cf (including Cf Control), Influenza Virus A, B, C (Class I — General Controls, product code GNX).

Submitted by Microscan Div. Baxter Healthcare Corp. (West Sacramento, US). The FDA issued a Cleared decision on June 26, 1987, 91 days after receiving the submission on March 27, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3330.

Submission Details

510(k) Number	K871231 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 27, 1987
Decision Date	June 26, 1987
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—