Formalin-Aceto-Alcohol Fixative

FDA 510(k) K842731 · E K Ind., Inc.

Substantially Equivalent

510(k) numberK842731

Submission

Device name
Formalin-Aceto-Alcohol Fixative
Applicant
E K Ind., Inc.
Mchenry, IL, US
Received
July 13, 1984
Decision date
September 11, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IGF – Solution, Formalin-Alcohol-Acetic Acid
Device class
Class I (low risk)
Regulation
21 CFR 864.4010
Specialty
Pathology

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K842936Acetic Acid, 3% V/VGGK · Traditional 09/12/1984SE
K842935Acetic Acid, 5% V/VGGK · Traditional 09/12/1984SE
K842934Decolorizing Fluic, Acid-Alcohol 3%PPM · Traditional 09/12/1984SE
K842933Carbol-Fuchsin, Ziehl-NeedsenICL · Traditional 09/11/1984SE
K842930Gomori's Trichrome StainLED · Traditional 09/11/1984SE
K842928Jenner Blood StainKJX · Traditional 09/11/1984SE
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Questions and answers

When was Formalin-Aceto-Alcohol Fixative cleared by the FDA?

Formalin-Aceto-Alcohol Fixative (K842731) received a 510(k) decision of Substantially Equivalent on September 11, 1984, 60 days after the submission was received.

What is the product code of K842731?

The FDA product code is IGF – Solution, Formalin-Alcohol-Acetic Acid, a Class I (low risk) device regulated under 21 CFR 864.4010.