Cleared Traditional

K905651 - KINETIC AMYLASE DETERMINATION
(FDA 510(k) Clearance)

K905651 · Biochemical Trade, Inc. · Chemistry
Jan 1991
Decision
44d
Days
Class 2
Risk

K905651 is an FDA 510(k) clearance for the KINETIC AMYLASE DETERMINATION, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on January 31, 1991, 44 days after receiving the submission on December 18, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K905651 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1990
Decision Date January 31, 1991
Days to Decision 44 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JFJ — Catalytic Methods, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

Similar Devices — JFJ Catalytic Methods, Amylase

All 98
Amylase2
K210633 · Abbott Ireland Diagnostics Division · May 2022
Atellica CH Amylase_2 (AMY_2)
K191454 · Siemens Healthcare Diagnostics, Inc. · Jul 2019
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
K182474 · Biosystems S.A. · May 2019
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
K130685 · Hitachi Chemical Diagnostics, Inc. · Aug 2013
ELTECH CHINICAL SYSTEM AMYLASE SL ELITECH CLINICAL SYSTEMS ELICAL2 ELTECH CLINICAL SYSTEMS ELITROL I AND ELITROL II
K122858 · Elitechgroup · Oct 2012
SYNCHRON SYSTEMS G7 AMYLASE (AMY7) REAGENT WITH MODEL(S) A71607
K091846 · Beckman Coulter, Inc. · Oct 2009