Gram Stain Kit

FDA 510(k) K781584 · Bioscientific

Substantially Equivalent

510(k) numberK781584

Submission

Device name
Gram Stain Kit
Applicant
Bioscientific
Mchenry, IL, US
Received
September 18, 1978
Decision date
October 10, 1978
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
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

More from Carr-Scarborough Microbiologicals, Inc.

510(k)DeviceDecision
K812447Amylase Reagent KitKHM · Traditional 09/09/1981SE
K811251Citrate BufferJCC · Traditional 05/21/1981SE
K801268Hemoglobin Control LevelsKHG · Traditional 07/14/1980SE
K801267Red Blood Cell Count & Hematocrit CNTLJPK · Traditional 07/14/1980SE
K801265White Blood Cell Count Control LevelsJPK · Traditional 07/14/1980SE
K791658Wright Stain Pack · Traditional 10/17/1979SE
K791007Stat Diff StainKQC · Traditional 08/03/1979SE
K790415HCP-7JPK · Traditional 04/04/1979SE
K781734Sodium Chloride, 0.85% · Traditional 10/24/1978SE
K781588Papanicolaou Stian OG-6HZJ · Traditional 10/10/1978SE

Questions and answers

When was Gram Stain Kit cleared by the FDA?

Gram Stain Kit (K781584) received a 510(k) decision of Substantially Equivalent on October 10, 1978, 22 days after the submission was received.

What is the product code of K781584?

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