Cleared Traditional

K874259 - TRICHOMONAS DIRECT ENZYME IMMUNOASSAY
(FDA 510(k) Clearance)

K874259 · California Integrated Diagnostics, Inc. · Microbiology

Dec 1987

Decision

48d

Days

Class 1

Risk

K874259 is an FDA 510(k) clearance for the TRICHOMONAS DIRECT ENZYME IMMUNOASSAY, a Kit, Screening, Trichomonas (Class I — General Controls, product code JWZ), submitted by California Integrated Diagnostics, Inc. (Berkeley, US). The FDA issued a Cleared decision on December 7, 1987, 48 days after receiving the submission on October 20, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K874259 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 1987
Decision Date	December 07, 1987
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—