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510(k) K840186

Device
SMI DIGITRON
Applicant
SCIENTIFIC MANUFACTURING INDUSTRIES
510(k) number
K840186
Product code
JRC  
Decision
Substantially Equivalent (SESE)
Decision date
1984-04-05
Date received
1984-01-18
Regulation
862.2050
Classification name
Micro Pipette
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JRC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K834100PRE-CALIBRATED PIPETTESVitex1984-02-21
K822078DADE DISP. DISPENSING-SPREADING PIPETSAmerican Dade1982-07-27
K792696MICROPITETTEMeridian Diagnostics, Inc.1980-02-01
K770594LABORATORY EXPENDABLE PRODUCTSAbco Dealers, Inc.1977-07-06
K760621LANCER PLASTIC TRANSFER PIPETTESherwood Medical Industries1976-10-05

Legacy Summary#

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FDA Review#

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