Gramstain Set

FDA 510(k) K821977 · Granite Diagnostics, Inc.

Substantially Equivalent

510(k) numberK821977

Submission

Device name
Gramstain Set
Applicant
Granite Diagnostics, Inc.
Mchenry, IL, US
Received
July 6, 1982
Decision date
July 22, 1982
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
K842733Gram IodineHYI · Traditional E K Ind., Inc.08/10/1984SE
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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Questions and answers

When was Gramstain Set cleared by the FDA?

Gramstain Set (K821977) received a 510(k) decision of Substantially Equivalent on July 22, 1982, 16 days after the submission was received.

What is the product code of K821977?

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