FDA.reportPublic FDA data

510(k) K801212

Device
WRIGHTS RAPID STAIN
Applicant
MCB MANUFACTURING CHEMISTS, INC.
510(k) number
K801212
Product code
IAF  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-30
Date received
1980-05-20
Regulation
864.1850
Classification name
Wright's Stain
Medical specialty
Hematology
Review panel
Hematology
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 IAF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K890674ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SETSigma Diagnostics, Inc.1989-02-24
K890673WRIGHT-GLEMSA STAINSigma Diagnostics, Inc.1989-02-24
K854236HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDSNms Pharmaceuticals, Inc.1986-10-10
K860793CAMCO STAIN PAKCambridge Chemical Products, Inc.1986-03-18
K853241HEMATOLOGY STAIN PACKFisher Scientific Co., LLC1985-08-19
K852138WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE SCanyon Diagnostics, Inc.1985-06-13
K842744WRIGHT STAINE K Ind., Inc.1984-08-12
K842745WRIGHT-GIEMSA QUICK STAINE K Ind., Inc.1984-08-10
K833678HEMATOLOGY WRIGHT'S STAIN PACKJ.S. Medical Assoc.1983-11-25
K833260STAIN PACK FOR AEROSPRAY SLIDE STAINERWescor, Inc.1983-10-28
K831605HEMATOLOGY PAKMercedes Scientific Co., Inc.1983-06-30
K830542HEMAQUIK II STAINING SOLUTION #55961Accra Laboratories, Inc.1983-03-17
K830127QUIK-DIP BLOOD STAINMercedes Scientific Co., Inc.1983-02-15
K822981MIDAS 1000 WRIGHT GIEMSA STAIN #66020Emd Chemicals, Inc.1982-10-27
K822980MIDAS 1000 WRIGHT STAIN #66010Emd Chemicals, Inc.1982-10-27

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