Cleared Traditional

K992665 - MACRA LP(A) ENZYME IMMUNOASSAY KIT
(FDA 510(k) Clearance)

K992665 · Trinity Biotech USA · Chemistry

Nov 1999

Decision

109d

Days

Class 2

Risk

K992665 is an FDA 510(k) clearance for the MACRA LP(A) ENZYME IMMUNOASSAY KIT, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Trinity Biotech USA (Jamestown, US). The FDA issued a Cleared decision on November 26, 1999, 109 days after receiving the submission on August 9, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number	K992665 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 09, 1999
Decision Date	November 26, 1999
Days to Decision	109 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement