Quick Stain Wright's Giemsa W/Buff

FDA 510(k) K833677 · J.S. Medical Assoc.

Substantially Equivalent

510(k) numberK833677

Submission

Device name
Quick Stain Wright's Giemsa W/Buff
Applicant
J.S. Medical Assoc.
Mchenry, IL, US
Received
October 18, 1983
Decision date
November 25, 1983
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
K842742Giemsa StainHYF · Traditional E K Ind., Inc.08/15/1984SE
K833665Hematology Wright's-Giemsa Satin PackHYF · Traditional J.S. Medical Assoc.11/25/1983SE
K831131Case Wright-Giemsa Stain PakHYF · Traditional Case Instruments06/08/1983SE

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Questions and answers

When was Quick Stain Wright's Giemsa W/Buff cleared by the FDA?

Quick Stain Wright's Giemsa W/Buff (K833677) received a 510(k) decision of Substantially Equivalent on November 25, 1983, 38 days after the submission was received.

What is the product code of K833677?

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