Case Wright-Giemsa Stain Pak

FDA 510(k) K831131 · Case Instruments

Substantially Equivalent

510(k) numberK831131

Submission

Device name
Case Wright-Giemsa Stain Pak
Applicant
Case Instruments
Mchenry, IL, US
Received
April 6, 1983
Decision date
June 8, 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
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

Questions and answers

When was Case Wright-Giemsa Stain Pak cleared by the FDA?

Case Wright-Giemsa Stain Pak (K831131) received a 510(k) decision of Substantially Equivalent on June 8, 1983, 63 days after the submission was received.

What is the product code of K831131?

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