Cleared Traditional

TITAN GEL HDL CHOLESTEROL KIT

K873547 · Helena Laboratories · Chemistry
Oct 1987
Decision
31d
Days
Class 1
Risk

About This 510(k) Submission

K873547 is an FDA 510(k) clearance for the TITAN GEL HDL CHOLESTEROL KIT, a Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBT), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on October 2, 1987, 31 days after receiving the submission on September 1, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K873547 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1987
Decision Date October 02, 1987
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code LBT — Electrophoresis, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

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