Giemsa Stain

FDA 510(k) K842742 · E K Ind., Inc.

Substantially Equivalent

510(k) numberK842742

Submission

Device name
Giemsa Stain
Applicant
E K Ind., Inc.
Mchenry, IL, US
Received
July 13, 1984
Decision date
August 15, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HYF – Giemsa Stain
Device class
Class I (low risk)
Regulation
21 CFR 864.1850
Specialty
Hematology

Other 510(k)s with product code HYF

510(k)DeviceApplicantDecision
K833677Quick Stain Wright's Giemsa W/BuffHYF · Traditional J.S. Medical Assoc.11/25/1983SE
K833665Hematology Wright's-Giemsa Satin PackHYF · Traditional J.S. Medical Assoc.11/25/1983SE
K831131Case Wright-Giemsa Stain PakHYF · Traditional Case Instruments06/08/1983SE

More from Case Instruments

510(k)DeviceDecision
K842931Drabkin ReagentKAG · Traditional 09/21/1984SE
K842938Acetic Acid 1% V/VGGK · Traditional 09/14/1984SE
K842937Acetic Acid 2% V/VGGK · Traditional 09/12/1984SE
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 Giemsa Stain cleared by the FDA?

Giemsa Stain (K842742) received a 510(k) decision of Substantially Equivalent on August 15, 1984, 33 days after the submission was received.

What is the product code of K842742?

The FDA product code is HYF – Giemsa Stain, a Class I (low risk) device regulated under 21 CFR 864.1850.