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510(k) K875310

Device
RETICULOCYTE STAIN
Applicant
SIGMA DIAGNOSTICS, INC.
510(k) number
K875310
Product code
KFC  
Decision
Substantially Equivalent (SESE)
Decision date
1988-02-09
Date received
1987-12-29
Regulation
864.1850
Classification name
Methylene Blue, Tissue Stain
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
TAKES, PHD
Address
P.O. Box 14508 St. Louis MO US 63178 63178

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KFC  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K843919SPOTTEST LOEFFLER METHYLENE BLUE STAINDifco Laboratories, Inc.1984-10-30
K842785STAIN, METHYLENE BLUE-EOSINReagent Laboratory, Inc.1984-09-11
K842926METHYLENE BLUE STAIN, LOEFFLERE K Ind., Inc.1984-09-11
K842743NEW METHYLENE BLUE NE K Ind., Inc.1984-08-12
K831502NEPHROLYTEFlaitron Laboratories, Inc.1983-07-18
K770792TUBE, STAIN, RETICULOCYTE, LARCCorning Medical & Scientific1977-07-05

Legacy Summary#

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FDA Review#

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