FDA.reportPublic FDA data

510(k) K792707

Device
PARA-PAK SAF
Applicant
MERIDIAN DIAGNOSTICS, INC.
510(k) number
K792707
Product code
IGG  
Decision
Substantially Equivalent (SESE)
Decision date
1980-01-21
Date received
1979-12-27
Regulation
864.4010
Classification name
Formaldehyde (formalin, Formol)
Medical specialty
Pathology
Review panel
Pathology
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 IGG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K882268ZINC FORMALIN CONCENTRATEAnatech, Ltd.1988-06-15
K861201FORMALDEHYDE SOLUTION, 37%Surgipath Medical Industries, Inc.1986-04-11
K81179437% FORMALDEHYDERichard-Allan Medical Ind., Inc.1981-07-28
K802506PLEASCENT OR FORMA-SCENTMeridian Diagnostics, Inc.1980-11-12
K792705PARA-PAK FORMALINMeridian Diagnostics, Inc.1980-01-21
K771201FORMALIN BUFFER CONCENTRATECentral Labs. Assoc. MD Pathologists1977-08-22

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