FDA.reportPublic FDA data

510(k) K882225

Device
-amylase Eps
Applicant
BOEHRINGER MANNHEIM CORP.
510(k) number
K882225
Product code
CIJ
Decision
Substantially Equivalent (SESE)
Decision date
1989-01-03
Date received
1988-05-26
Regulation
862.1070
Classification name
Saccharogenic, Amylase
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHERI EMMONS
Address
9115 Hague Rd. Indianapolis IN US 46250 46250

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CIJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K023396AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)Pointe Scientific, Inc.,2002-12-23
K991817ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEMBayer Corp.1999-07-22
K980013AMYLASEAc Biochemicals, Inc.1998-02-04
K953211AMYLASE (ETHYLIDENE PNGPG7) KITRandox Laboratories, Ltd.1996-06-21
K951494AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)Emd Chemicals, Inc.1995-12-11
K940735LIQUID AMYLASE (CNPG3) REAGENT SETPointe Scientific, Inc.,1994-08-01
K940010DMA AMYLASE (DEMAND) PROCEDUREData Medical Associates, Inc.1994-03-11
K931301OLYMPUS AMYLASE REAGENTOlympus Corp.1993-10-18
K931141BIOTROL AMYLASE CNPG3Biotrol, USA, Inc.1993-05-26
K873572IL 35260, IL TEST AMYLASE REAGENTInstrumentation Laboratory CO1987-10-20
K873250ISOMUNE-AMYLASE AND ISOMUNE-AMYLASE CONTROLRoche Diagnostic Systems, Inc.1987-10-20
K872831BIOTROL ALPHA AMYLASEBiotrol, USA, Inc.1987-09-04
K871943D.A.T. (TM) AMYLASE REAGENTBehring Diagnostics, Inc.1987-06-03
K864356AMYLASE REAGENTTrace Scientific , Ltd.1987-01-21
K863719AMYLASE,CALCIUM,CHLORIDE & TRIGLYCERIDES ON CHEM 1Technicon Instruments Corp.1986-11-13