Cleared Traditional

ABC, ABC-1X, ABC(TM)

K890482 · Cell Ent., Inc. · Pathology

Feb 1989

Decision

10d

Days

Class 1

Risk

About This 510(k) Submission

K890482 is an FDA 510(k) clearance for the ABC, ABC-1X, ABC(TM), a Media And Components, Synthetic Cell And Tissue Culture (Class I — General Controls, product code KIT), submitted by Cell Ent., Inc. (Derwood, US). The FDA issued a Cleared decision on February 10, 1989, 10 days after receiving the submission on January 31, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number	K890482 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 31, 1989
Decision Date	February 10, 1989
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	—