Panels › Clinical Chemistry › Product code JFJ · Class 2

Catalytic Methods, Amylase

Regulation 862.1070

0510(k)s in 12 months (99 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

Top companies in JFJ

Company	510(k)s	Recalls
Em Diagnostic Systems, Inc.	7	0
Abbott Laboratories	6	0
Genzyme Corp.	4	0
Pointe Scientific, Inc.,	4	0
Boehringer Mannheim Corp.	3	0
Data Medical Associates, Inc.	3	0
Diagnostic Chemicals , Ltd.	3	0
Harleco	3	0
Instrumentation Laboratory CO	3	0
Sclavo, Inc.	3	0

Date	Firm and product	Code	Linked 510(k)
Jul 10, 2020	RANDOX LABORATORIES, LTD. Pancreatic Amylase AY3855 batch 480483 Pancreatic Amylase Ethylidene Blocked-pNPG7 Reagent Terminated	JFJ	K971825
Feb 8, 2008	Roche Diagnostics Corp. Roche LIPC Lipase Colorimetric Reagent; Catalog Number: 03029590322. Roche Diagnostics Corp., Indianapolis, IN 46250 Terminated	JFJ	K972250

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