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510(k) K843050

Device
GRAM STAIN
Applicant
REAGENT LABORATORY, INC.
510(k) number
K843050
Product code
JTS  
Decision
Substantially Equivalent (SESE)
Decision date
1984-09-11
Date received
1984-08-03
Regulation
864.1850
Classification name
Stains, Microbiologic
Medical specialty
Hematology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JTS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K960095BACTIDROP CALCOFLUOR WHITERemel Co.1996-03-19
K960090CALCOFLUOR WHITE STAIN KITRemel Co.1996-03-19
K920976BACTIDROP INDIA INKRemel Co.1992-06-09
K920975BACTIDROP CALCOFLUOR WHITERemel Co.1992-06-09
K920970BACTIDROP KOH (10%)Remel Co.1992-06-09
K893530IRISTAIN FORMULA 2, PARTS 1 AND 2Intl. Remote Imaging Systems1989-06-13
K890861ATS DOBELL & O'CONNOR'S IODINEAlpha-Tec Systems, Inc.1989-03-23
K890020ATS LUGOL'S IODINE SOLUTIONAlpha-Tec Systems, Inc.1989-02-24
K884069SNAP N' STAIN IODINE STAINScientific Device Laboratory, Inc.1988-10-25
K883052METHENO-STAIN KITScientific Device Laboratory, Inc.1988-08-30
K883061ATS PARA-SET CARBOL-XYLENE SOLUTIONAlpha-Tech Systems, Inc.1988-08-17
K883049ATS PARA-SET IODINE ALCOHOL SOLUTIONAlpha-Tec Systems, Inc.1988-08-17
K880989ATS CRYPTOSPORIDIUM STAIN SETAlpha-Tec Systems, Inc.1988-05-13
K881598SDL TRICHROME STAINScientific Device Laboratory, Inc.1988-05-04
K881512WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAYWescor, Inc.1988-04-18

Legacy Summary#

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FDA Review#

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