Cleared Traditional

POLYCHACO INDIRECT IMMUNOFLUORESCENCE

K830869 · Parasitic Disease Consultants · Microbiology

Aug 1983

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K830869 is an FDA 510(k) clearance for the POLYCHACO INDIRECT IMMUNOFLUORESCENCE, a Antigens, If, Toxoplasma Gondii (Class II — Special Controls, product code GLZ), submitted by Parasitic Disease Consultants (Mchenry, US). The FDA issued a Cleared decision on August 11, 1983, 146 days after receiving the submission on March 18, 1983. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number	K830869 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 1983
Decision Date	August 11, 1983
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—