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510(k) K803095

Device
COPPER SULFATE SOLUTION SP. GR.1.055
Applicant
ACCRA LABORATORIES, INC.
510(k) number
K803095
Product code
KSL  
Decision
Substantially Equivalent (SESE)
Decision date
1981-03-06
Date received
1980-12-08
Regulation
864.9320
Classification name
Solution, Copper Sulfate For Specific Gravity Determinations
Medical specialty
Hematology
Review panel
Hematology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KSL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882101HEMOGLOBIN SCREENING DEVICEPortable Medical Laboratories, Inc.1988-07-01

Legacy Summary#

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FDA Review#

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