Cleared Traditional

K855205 - MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM (FDA 510(k) Clearance)

K855205 · Hana Biologics, Inc. · Microbiology device

Feb 1986

Decision

37d

Days

Class 1

Risk

K855205 is an FDA 510(k) clearance for the MYCOTRIM TM VL TRIPHASIC CULTURE SYSTEM. This device is classified as a Culture Media, Selective And Differential (Class I - General Controls, product code JSI).

Submitted by Hana Biologics, Inc. (Berkeley, US). The FDA issued a Cleared decision on February 5, 1986, 37 days after receiving the submission on December 30, 1985.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2360.

Submission Details

510(k) Number	K855205 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 30, 1985
Decision Date	February 05, 1986
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—