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510(k) K842310

Device
HEMATOLOGY ANALYZER
Applicant
HML INC/BIOTECHNOLOGY TRANSFER
510(k) number
K842310
Product code
JKL  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-06
Date received
1984-06-12
Regulation
862.1060
Classification name
Acid, Delta-aminolevulinic, Ion-exchange Columns With Colorimetry
Medical specialty
Clinical Chemistry
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 JKL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K921534DSL DHEA (DSL 8900)Diagnostic Systems Laboratories, Inc.1992-05-26

Legacy Summary#

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FDA Review#

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