Cleared Traditional

K823016 - CANDIDA DETECTION SYSTEM (FDA 510(k) Clearance)

K823016 · Ramco Laboratories, Inc. · Microbiology device

Dec 1982

Decision

77d

Days

Class 2

Risk

K823016 is an FDA 510(k) clearance for the CANDIDA DETECTION SYSTEM. This device is classified as a Antigen, Id, Candida Albicans (Class II - Special Controls, product code LHK).

Submitted by Ramco Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982, 77 days after receiving the submission on October 12, 1982.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3165.

Submission Details

510(k) Number	K823016 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 12, 1982
Decision Date	December 28, 1982
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—