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510(k) K890148

Device
ATS TB RAPID STAIN SET PRODUCT #034-45
Applicant
ALPHA-TEC SYSTEMS, INC.
510(k) number
K890148
Product code
ICL  
Decision
Substantially Equivalent (SESE)
Decision date
1989-01-24
Date received
1989-01-13
Regulation
864.1850
Classification name
Carbol Fuchsin
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LAURIE A WILLIAMS
Address
P.O. Box 17196 Irvine CA US 92713 92713

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ICL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K842933CARBOL-FUCHSIN, ZIEHL-NEEDSENE K Ind., Inc.1984-09-11
K792483STAINS, COUNTERSTAINS & GEN. PURPOSELaboratory Products, Inc.1979-12-18
K771390HISTOCHEMICAL AFB DEMONSTRATIONHarleco1977-08-22

Legacy Summary#

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FDA Review#

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