Cleared Traditional

K871229 - ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL
(FDA 510(k) Clearance)

K871229 · Microscan Div. Baxter Healthcare Corp. · Microbiology

Jun 1987

Decision

91d

Days

Class 1

Risk

K871229 is an FDA 510(k) clearance for the ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL. This device is classified as a Antigens, Cf (including Cf Control), Adenovirus 1-33 (Class I — General Controls, product code GOD).

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 866.3020.

Submission Details

510(k) Number	K871229 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	—