Cleared Traditional

REAGENT, AMYLASE LIPASE

K770400 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Chemistry
Apr 1977
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K770400 is an FDA 510(k) clearance for the REAGENT, AMYLASE LIPASE, a Nephelometric, Amylase (Class II — Special Controls, product code KHM), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on April 26, 1977, 55 days after receiving the submission on March 2, 1977. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K770400 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 1977
Decision Date April 26, 1977
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code KHM — Nephelometric, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070