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510(k) K904022

Device
NITRO BLUE TETRAZOLIUM REDUCTION
Applicant
SIGMA CHEMICAL CO.
510(k) number
K904022
Product code
GHD  
Decision
Substantially Equivalent (SESE)
Decision date
1990-12-18
Date received
1990-08-30
Regulation
864.7660
Classification name
Test, Leukocyte Alkaline Phosphatase
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TAKES, PH.D
Address
545 S. Ewing Ave. St. Louis MO US 63103 63103

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GHD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K903995NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KITSigma Chemical Co.1990-12-13
K896092ALKALINE PHOSPHATASE, LEUKOCYTE, KITSigma Chemical Co.1989-11-09
K811189CHEMSTRIP LBiodynamics Corp.1981-07-27

Legacy Summary#

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FDA Review#

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