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

FDA 510(k) K182474 · Biosystems S.A.

Substantially Equivalent

510(k) numberK182474

Submission

Device name
alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL
Applicant
Biosystems S.A.
Barcelona, ES
Received
September 10, 2018
Decision date
May 2, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
JFJ – Catalytic Methods, Amylase
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1070
Specialty
Clinical Chemistry

Other 510(k)s with product code JFJ

510(k)DeviceApplicantDecision
K210633Amylase2JFJ · Traditional Abbott Ireland Diagnostics Division05/26/2022SE
K191454Atellica CH Amylase_2 (AMY_2)JFJ · Traditional Siemens Healthcare Diagnostics, Inc.07/30/2019SE
K130685Hitachi Clinical Analyzer S Test Reagent Cartridges for LD and AmyJFJ · Traditional Hitachi Chemical Diagnostics, Inc.08/09/2013SE
K122858Eltech Chinical System Amylase SL Elitech Clinical Systems ELICAL2 Eltech Clinical…JFJ · Traditional Elitechgroup10/03/2012SE
K091846Synchron Systems G7 Amylase (AMY7) Reagent with Model(S) A71607JFJ · Traditional Beckman Coulter, Inc.10/16/2009SE
K080823Easyra Amylase, Bun, Glu-H, Trig, Uric ReagentJFJ · Traditional Medica Corp.11/17/2008SE
K070064Amylase Eps ReagentJFJ · Traditional Thermo Fisher Scientific05/22/2007SE
K062180Abx Pentra Amylase CP; Multical; N Control; P Control; Clean-Chem CP; Clean-Chem 99 CPJFJ · Traditional Horiba Abx10/02/2006SE
K051447Sentinel Pancreatic AmylaseJFJ · Traditional Sentinel Ch. Srl01/26/2006SE
K040920Amylase Liquid Reagent, Model A532-200JFJ · Special Teco Diagnostics05/10/2004SE

More from Teco Diagnostics

510(k)DeviceDecision
K192730Calcium-Cresolphthalein, Glucose, Urea/Bun-UvCHW · Traditional 09/09/2020SE
K190495TransferrinDDG · Traditional 03/16/2020SE
K170901Albumin, Alkaline Phosphatase (Alp)-Amp, Glucose-Hexokinase, BA400CIX · Traditional 04/13/2018SE

Questions and answers

When was alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL cleared by the FDA?

alpha-AMYLASE DIRECT, alpha-AMYLASE EPS, alpha-AMYLASE PANCREATIC, BILIRUBIN DIRECT, BILIRUBIN TOTAL (K182474) received a 510(k) decision of Substantially Equivalent on May 2, 2019, 234 days after the submission was received.

What is the product code of K182474?

The FDA product code is JFJ – Catalytic Methods, Amylase, a Class II (moderate risk) device regulated under 21 CFR 862.1070.