FDA.reportPublic FDA data

510(k) K822784

Device
HEMO-DE
Applicant
PMP INDUSTRIES
510(k) number
K822784
Product code
KEM  
Decision
Substantially Equivalent (SESE)
Decision date
1982-11-05
Date received
1982-09-14
Regulation
864.4010
Classification name
Agent, Clearing
Medical specialty
Pathology
Review panel
Pathology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
Anaheim CA US

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KEM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K881282XYLENEAnatech, Ltd.1988-04-05
K874461HEMO-SOLChem Pharm, Inc.1987-12-04
K861490PERMACLEAR SOLUTION CAT. NO. 4950Helena Laboratories1986-05-06
K855109CLEARENE, CLEARING AGENTSurgipath Medical Industries, Inc.1986-01-07
K853694XYLENE SUBSTITUTELerner Laboratories, Inc.1985-10-22
K854083XYLENE SUBSTITUTE MONTANTLerner Laboratories, Inc.1985-10-22
K842861PRO-PAR CLEARANTAnatech, Ltd.1984-08-21
K842721LIMONENEE K Ind., Inc.1984-08-03
K832011AMERI CLEARStephens Scientific1983-08-12
K832451CLEAR-RITE 3Richard-Allan Medical Ind., Inc.1983-08-12
K830627CLARIFIER-RICHARD-ALLANRichard-Allan Medical Ind., Inc.1983-03-24
K812846CLEAR-RITE IIRichard-Allan Medical Ind., Inc.1981-10-29
K812847XYLENERichard-Allan Medical Ind., Inc.1981-10-29
K811798CLEAR-RITERichard-Allan Medical Ind., Inc.1981-07-28

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