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510(k) K023046

Device
SST SALIVA SUPPORTING TABLETS
Applicant
SINCLAIR PHARMACEUTICALS, LTD.
510(k) number
K023046
Product code
LED  
Decision
Substantially Equivalent (SESE)
Decision date
2002-12-02
Date received
2002-09-12
Regulation
864.1850
Classification name
Stains, Chemical Solution
Medical specialty
Hematology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DENISE SWIFT
Address
Borough Rd. Godalming, Surrey GB GU7 2AB GU7 2AB

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LED  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K051409SLIVASUREScandinavian Formulas, Inc.2005-08-08
K860795SPOTTEST CALCOFLUOR WHITE REAGENTDifco Laboratories, Inc.1986-03-12
K860316PANOPTIKONCytocolor, Inc.1986-02-20
K860317NEUTROCOLORCytocolor, Inc.1986-02-20
K860319MEGACOLORCytocolor, Inc.1986-02-20
K860320GRANULOCOLORCytocolor, Inc.1986-02-20
K860321LYSOCOLORCytocolor, Inc.1986-02-20
K854176POLYCHROME IV STAINDevetec, Inc.1985-10-31
K851481SPOTTEST IODINE SOLUTION DOBELL & O'CONNORDifco Laboratories, Inc.1985-04-29
K842930GOMORI'S TRICHROME STAINE K Ind., Inc.1984-09-11
K842727SUPERMOUNTE K Ind., Inc.1984-08-03
K840087PRESERV GOMORI TRICHROME STAIN 125/500Preventive Diagnostics Corp.1984-02-10
K833167TRICHROME STAIN LG SOLUTIONSigma Chemical Co.1983-10-31
K833388IRON STAIN PROCEDURE HT20Sigma Chemical Co.1983-10-31
K812192LACTO-PHENOL ANILINE BLUE MOUNTING FLUIDAmerican Scientific Products1981-08-31

Legacy Summary#

summary

FDA Review#

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