Cleared Traditional

SEROCLUSTER FLEXIBLE VINYL U & V PL.

K803243 · Corning Costar Corp. · Immunology

Jan 1981

Decision

36d

Days

Class 1

Risk

About This 510(k) Submission

K803243 is an FDA 510(k) clearance for the SEROCLUSTER FLEXIBLE VINYL U & V PL., a Device, Microtiter Diluting/dispensing (Class I — General Controls, product code JTC), submitted by Corning Costar Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981, 36 days after receiving the submission on December 23, 1980. This device falls under the Immunology review panel. Regulated under 21 CFR 866.2500.

Submission Details

510(k) Number	K803243 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 23, 1980
Decision Date	January 28, 1981
Days to Decision	36 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—