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510(k) K933836

Device
HBM HEMOGLOBINOMETER
Applicant
ARTEL, INC.
510(k) number
K933836
Product code
GIG  
Decision
Substantially Equivalent (SESE)
Decision date
1994-03-31
Date received
1993-08-05
Regulation
864.7500
Classification name
Hemoglobinometer
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CHARLES EWING
Address
12 Depot St. Windham ME US 04062 04062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code GIG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K973995RANDOX BILIRUBINRandox Laboratories, Ltd.1997-12-08
K771101HEMOGLOBIN ANALYZER & PERFORM. CHECK SETThe Dow Chemical Co.1977-07-21

Legacy Summary#

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FDA Review#

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