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510(k) K810836

Device
DECALCIFIER II
Applicant
SURGIPATH
510(k) number
K810836
Product code
KDX  
Decision
Substantially Equivalent (SESE)
Decision date
1981-04-23
Date received
1981-03-26
Regulation
864.4010
Classification name
Solution, Decalcifier, Acid Containing
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 KDX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K872625DECALCIFYING SOLUTIONStephens Scientific1987-08-06
K850636SIMUTANEOUS FIXATION & DECALCIFYING SOLUTION CAL-EFisher Scientific Co., LLC1985-03-20
K842726DECALCIFIER SOLUTIONE K Ind., Inc.1984-08-03
K841488DECALCIFIER ISurgipath Medical Industries, Inc.1984-05-02
K822036VOLU-SOL DECALCIFERVolu Sol Medical Industries1982-08-03
K821443FORMICALLerner Laboratories, Inc.1982-06-02
K811801CAL-RITERichard-Allan Medical Ind., Inc.1981-07-28

Legacy Summary#

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FDA Review#

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