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510(k) K791711

Device
IMPROVED GRAM STAIN REAGENTS
Applicant
CARR-SCARBOROUGH MICROBIOLOGICALS, INC.
510(k) number
K791711
Product code
HYI  
Decision
Substantially Equivalent (SESE)
Decision date
1979-10-17
Date received
1979-08-28
Regulation
864.1850
Classification name
Iodine, Grams
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 HYI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871286GRAM IODINERemel Co.1987-04-08
K842733GRAM IODINEE K Ind., Inc.1984-08-10
K821977GRAMSTAIN SETGranite Diagnostics, Inc.1982-07-22
K811722PARA-PAKMeridian Diagnostics, Inc.1981-07-15
K781584GRAM STAIN KITBioscientific1978-10-10

Legacy Summary#

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FDA Review#

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