Gram Iodine

FDA 510(k) K842733 · E K Ind., Inc.

Substantially Equivalent

510(k) numberK842733

Submission

Device name
Gram Iodine
Applicant
E K Ind., Inc.
Mchenry, IL, US
Received
July 13, 1984
Decision date
August 10, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HYI – Iodine, Grams
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code HYI

510(k)DeviceApplicantDecision
K871286Gram IodineHYI · Traditional Remel Co.04/08/1987SE
K821977Gramstain SetHYI · Traditional Granite Diagnostics, Inc.07/22/1982SE
K811722Para-PakHYI · Traditional Meridian Diagnostics, Inc.07/15/1981SE
K791711Improved Gram Stain ReagentsHYI · Traditional Carr-Scarborough Microbiologicals, Inc.10/17/1979SE
K781584Gram Stain KitHYI · Traditional Bioscientific10/10/1978SE

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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
K842927Light Green SF 1%HYS · Traditional 09/11/1984SE

Questions and answers

When was Gram Iodine cleared by the FDA?

Gram Iodine (K842733) received a 510(k) decision of Substantially Equivalent on August 10, 1984, 28 days after the submission was received.

What is the product code of K842733?

The FDA product code is HYI – Iodine, Grams, a Class I (low risk) device regulated under 21 CFR 864.1850.