Cleared Traditional

POLYCHACO INDIRECT HEMAGGLUTINATION

K830870 · Parasitic Disease Consultants · Microbiology

Aug 1983

Decision

147d

Days

Class 2

Risk

About This 510(k) Submission

K830870 is an FDA 510(k) clearance for the POLYCHACO INDIRECT HEMAGGLUTINATION, a Antigens, Iha, Toxoplasma Gondii (Class II — Special Controls, product code GMM), submitted by Parasitic Disease Consultants (Mchenry, US). The FDA issued a Cleared decision on August 12, 1983, 147 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	K830870 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 18, 1983
Decision Date	August 12, 1983
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—