Cleared Traditional

K893036 - ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS)
(FDA 510(k) Clearance)

K893036 · Amersham Corp. · Immunology

Jun 1989

Decision

39d

Days

Class 2

Risk

K893036 is an FDA 510(k) clearance for the ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS), a Anti-dna Antibody (enzyme-labeled), Antigen, Control (Class II — Special Controls, product code LRM), submitted by Amersham Corp. (Arlington Heights, US). The FDA issued a Cleared decision on June 2, 1989, 39 days after receiving the submission on April 24, 1989. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K893036 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 1989
Decision Date	June 02, 1989
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—