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510(k) K792101

Device
COUITER/CMS ISOTONIC BLOOD BANK SALINE
Applicant
COULTER ELECTRONICS, INC.
510(k) number
K792101
Product code
JCE  
Decision
Substantially Equivalent (SESE)
Decision date
1979-11-20
Date received
1979-10-19
Regulation
864.4010
Classification name
Solution, Isotonic
Medical specialty
Pathology
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 JCE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842722BUFFERED SALINEE K Ind., Inc.1984-09-11
K831200IMMUNOHEMATOLOGICAL SALINE #97139Emd Chemicals, Inc.1983-05-09
K801506CERTIFIED BLOOD BANK SALINENobel Scientific Industries, Inc.1980-07-28
K761183LYSING AGENT AFCentral Labs. Assoc. MD Pathologists1977-01-17
K761170BARBITAL SALINE BUFFERBio/Data Corp.1977-01-10
K761174PHYSIOLOGIC SALINE (0.85%)Bio/Data Corp.1977-01-10

Legacy Summary#

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FDA Review#

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