Quik-Sep Quantitative Hemoglobin S Assay

FDA 510(k) K942276 · Isolab, Inc.

Substantially Equivalent

510(k) numberK942276

Submission

Device name
Quik-Sep Quantitative Hemoglobin S Assay
Applicant
Isolab, Inc.
Akron, OH, US
Received
May 10, 1994
Decision date
January 20, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GIQ – Hemoglobin S
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7415
Specialty
Hematology

Other 510(k)s with product code GIQ

510(k)DeviceApplicantDecision
K955719SICKLE-2000GIQ · Traditional Medicus Technologies, Inc.08/14/1996SE
K874429Hemoglobin Determination Test Kit HGB S-100 & 12GIQ · Traditional Hf Scientific, Inc.02/04/1988SE

More from Hf Scientific, Inc.

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K943547Phenylalanine Test KitJNB · Traditional 01/26/1996SE
K950803Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional 09/21/1995SE
K950415Fluoroscan NeonatalKHO · Traditional 09/05/1995SE
K942222Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional 01/20/1995SE
K944185IsoscanJQT · Traditional 11/17/1994SE
K934013Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional 04/26/1994SE
K923153Hemocard, Hemoglobin C AssayMLL · Traditional 01/27/1994SE
K931234Hemocard Control Hb-Aa, Ae, Faa, FaeJCM · Traditional 05/11/1993SE

Questions and answers

When was Quik-Sep Quantitative Hemoglobin S Assay cleared by the FDA?

Quik-Sep Quantitative Hemoglobin S Assay (K942276) received a 510(k) decision of Substantially Equivalent on January 20, 1995, 255 days after the submission was received.

What is the product code of K942276?

The FDA product code is GIQ – Hemoglobin S, a Class II (moderate risk) device regulated under 21 CFR 864.7415.