FDA.reportPublic FDA data

510(k) K871533

Device
TOMTEC GRAM STAINER DECOLORIZER
Applicant
REMEL CO.
510(k) number
K871533
Product code
PPM  
Decision
Substantially Equivalent (SESE)
Decision date
1987-04-29
Date received
1987-04-20
Regulation
864.4010
Classification name
General Purpose Reagent
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JAMES G BAXENDALE
Address
12076 Santa Fe Dr. Lenexa KS US 66215 66215

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code PPM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K863550POTASSIUM HYDROXIDE 10% W/VReagent Laboratory, Inc.1986-10-02
K861890100%, 95%, 80% & 70% DEHYDRANT CUSTOM BLEND NO. 2Richard-Allan Medical Ind., Inc.1986-06-03
K850916SPRAYFIXSurgipath Medical Industries, Inc.1985-03-25
K850737TRANSPORT CULTURE MEDIUMRoseville Medical Laboratoriesu1985-03-20
K8508450.85% SALINEMicro Media Laboratories1985-03-20
K842934DECOLORIZING FLUIC, ACID-ALCOHOL 3%E K Ind., Inc.1984-09-12
K842863PRO-SOFT DEHYDRANTAnatech, Ltd.1984-08-21
K842729DECOLORIZING FLUIDE K Ind., Inc.1984-08-03
K842070IDD DETERGENTInterscience Diagnostics, Inc.1984-07-02
K831619SODIUM HYPOCHLORITE 7%Omega Medical Diagnostics1983-07-28
K831620SODIUM HYPOCHLORITE 3%Omega Medical Diagnostics1983-07-28
K822326BLENDED DETERGENT-78N 1912-1Interscience, Inc.1982-10-18
K822037VOLU-SOL TAP WATER SUBSTITUTEVolu Sol Medical Industries1982-08-03
K811800BLUING REAGENTRichard-Allan Medical Ind., Inc.1981-08-12
K811796FORMAL ALCOHOLRichard-Allan Medical Ind., Inc.1981-07-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases