Cleared Traditional

IMMUNO-CEPT D (BETA-MONOCLONAL)

K863741 · Immunostics Co., Inc. · Chemistry

Nov 1986

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K863741 is an FDA 510(k) clearance for the IMMUNO-CEPT D (BETA-MONOCLONAL), a Agglutination Method, Human Chorionic Gonadotropin (Class II — Special Controls, product code JHJ), submitted by Immunostics Co., Inc. (Ocean, US). The FDA issued a Cleared decision on November 13, 1986, 51 days after receiving the submission on September 23, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1155.

Submission Details

510(k) Number	K863741 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 23, 1986
Decision Date	November 13, 1986
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—