Cleared Traditional

H-I-M-TEST FOR DETECTING HUMAN CHOR. GON

K800055 · Technam, Inc. · Chemistry

Jan 1980

Decision

19d

Days

Class 2

Risk

About This 510(k) Submission

K800055 is an FDA 510(k) clearance for the H-I-M-TEST FOR DETECTING HUMAN CHOR. GON, a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Technam, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 29, 1980, 19 days after receiving the submission on January 10, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K800055 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 1980
Decision Date	January 29, 1980
Days to Decision	19 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—