FDA.reportPublic FDA data

510(k) K840926

Device
Formalin Solution 10% Neutral Buffer
Applicant
SIGMA CHEMICAL CO.
510(k) number
K840926
Product code
IFP
Decision
Substantially Equivalent (SESE)
Decision date
1984-03-12
Date received
1984-03-02
Regulation
864.4010
Classification name
Formalin, Neutral Buffered
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 IFP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884755CONSED FECAL CONCENTRATION SYSTEMDonald L. Price, Ph.D.1989-01-10
K872663DRY-FORMAnatech, Ltd.1987-08-06
K872140(MSI) PATH-SAVERMedical Specialties, Inc.1987-06-15
K870852NBF 10% NEUTRAL BUFFERED FORMALINAnatech, Ltd.1987-03-31
K853497PREFILLED SPECIMEN JARS 10% NEUTRAL BUF-FORMALINSurgipath Medical Industries, Inc.1985-08-28
K842982FORMALIN BUFFEREDReagent Laboratory, Inc.1984-10-01
K842940CBA FORMALINAnatech, Ltd.1984-08-28
K842728BUF-FIXE K Ind., Inc.1984-08-03
K830582MILLONIG'S MODIFIED PHOSPHATE BUFFEREDSurgipath Medical Industries, Inc.1983-03-17
K830583NEUTRAL BUFFERED FORMALIN 10%Surgipath Medical Industries, Inc.1983-03-17
K830514MILLONIGS MODIFIED PHOSPHATE BUFFEREDSurgipath Medical Industries, Inc.1983-03-08
K81294010% NEUTRAL BUFFERED FORMALIN CONCENTSurgipath1981-12-10
K812817NEUTRAL DUFFERED FORMA-SCENTMeridian Diagnostics, Inc.1981-11-10
K81179510% NEUTRAL BUFFERED FORMALDEHYDERichard-Allan Medical Ind., Inc.1981-07-28