Cleared Traditional

K897077 - ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE
(FDA 510(k) Clearance)

K897077 · Gen-Probe, Inc. · Microbiology

Aug 1990

Decision

244d

Days

Class 1

Risk

K897077 is an FDA 510(k) clearance for the ACCUPROBE MYCOBACTERIUM INTRACELLULARE CULTURE. This device is classified as a Dna-reagents, Mycobacterium Spp. (Class I — General Controls, product code LQF).

Submitted by Gen-Probe, Inc. (San Diego, US). The FDA issued a Cleared decision on August 23, 1990, 244 days after receiving the submission on December 22, 1989.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3370.

Submission Details

510(k) Number	K897077 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 1989
Decision Date	August 23, 1990
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—