Cleared Traditional

K000749 - RHIGENE MESACUP2 TEST- SSA
(FDA 510(k) Clearance)

K000749 · Rhigene, Inc. · Immunology

May 2000

Decision

62d

Days

Class 2

Risk

K000749 is an FDA 510(k) clearance for the RHIGENE MESACUP2 TEST- SSA. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II — Special Controls, product code LLL).

Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 9, 2000, 62 days after receiving the submission on March 8, 2000.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K000749 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 08, 2000
Decision Date	May 09, 2000
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement