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IGG — Formaldehyde (Formalin, Formol) Class I

FDA Device Classification

Classification Details

Product Code
IGG
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
K882268anatechZINC FORMALIN CONCENTRATEJune 15, 1988
K861201surgipath medical industriesFORMALDEHYDE SOLUTION, 37%April 11, 1986
K811794richard-allan medical ind37% FORMALDEHYDEJuly 28, 1981
K802506meridian diagnosticsPLEASCENT OR FORMA-SCENTNovember 12, 1980
K792707meridian diagnosticsPARA-PAK SAFJanuary 21, 1980
K792705meridian diagnosticsPARA-PAK FORMALINJanuary 21, 1980
K771201central labs. assoc. md pathologistsFORMALIN BUFFER CONCENTRATEAugust 22, 1977