Cleared Traditional

HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT

K970477 · Sebia · Chemistry
Mar 1997
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K970477 is an FDA 510(k) clearance for the HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT, a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code CFE), submitted by Sebia (Chelsea, US). The FDA issued a Cleared decision on March 10, 1997, 31 days after receiving the submission on February 7, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number K970477 FDA.gov
FDA Decision Cleared SESE
Date Received February 07, 1997
Decision Date March 10, 1997
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1445

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