Cleared Traditional

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL

K182474 · Biosystems S.A. · Chemistry
May 2019
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K182474 is an FDA 510(k) clearance for the alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL, a Catalytic Methods, Amylase (Class II — Special Controls, product code JFJ), submitted by Biosystems S.A. (Barcelona, ES). The FDA issued a Cleared decision on May 2, 2019, 234 days after receiving the submission on September 10, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K182474 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 2018
Decision Date May 02, 2019
Days to Decision 234 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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
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
EASYRA AMYLASE, BUN, GLU-H, TRIG, URIC REAGENT
K080823 · Medica Corp. · Nov 2008