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510(k) K861490

Device
Permaclear Solution Cat. No. 4950
Applicant
HELENA LABORATORIES
510(k) number
K861490
Product code
KEM
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-06
Date received
1986-04-22
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#

Contact
PAT FRANKS
Address
1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704

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
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
K822784HEMO-DEPmp Industries1982-11-05
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