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KEM — Agent, Clearing Class I

FDA Device Classification

Classification Details

Product Code
KEM
Device Class
Class I
Regulation Number
864.4010
Submission Type
Review Panel
PA
Medical Specialty
Pathology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K881282anatechXYLENEApril 5, 1988
K874461chem pharmHEMO-SOLDecember 4, 1987
K861490helena laboratoriesPERMACLEAR SOLUTION CAT. NO. 4950May 6, 1986
K855109surgipath medical industriesCLEARENE, CLEARING AGENTJanuary 7, 1986
K854083lerner laboratoriesXYLENE SUBSTITUTE MONTANTOctober 22, 1985
K853694lerner laboratoriesXYLENE SUBSTITUTEOctober 22, 1985
K842861anatechPRO-PAR CLEARANTAugust 21, 1984
K842721e k indLIMONENEAugust 3, 1984
K832451richard-allan medical indCLEAR-RITE 3August 12, 1983
K832011stephens scientificAMERI CLEARAugust 12, 1983
K830627richard-allan medical indCLARIFIER-RICHARD-ALLANMarch 24, 1983
K822784pmp industriesHEMO-DENovember 5, 1982
K812847richard-allan medical indXYLENEOctober 29, 1981
K812846richard-allan medical indCLEAR-RITE IIOctober 29, 1981
K811798richard-allan medical indCLEAR-RITEJuly 28, 1981