Hemoglobin Determination Test Kit HGB S-100 & 12

FDA 510(k) K874429 · Hf Scientific, Inc.

Substantially Equivalent

510(k) numberK874429

Submission

Device name
Hemoglobin Determination Test Kit HGB S-100 & 12
Applicant
Hf Scientific, Inc.
Ft. Myers, FL, US
Received
October 28, 1987
Decision date
February 4, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K942276Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional Isolab, Inc.01/20/1995SE

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K882801Rinse & Reference Solution/Buffer/Low & High Stan.JGS · Traditional 08/29/1988SE
K880967Micro CO2 ApparatusCIE · Traditional 04/28/1988SE
K864313CO2 Reagent SetCIE · Traditional 03/13/1987SE
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Questions and answers

When was Hemoglobin Determination Test Kit HGB S-100 & 12 cleared by the FDA?

Hemoglobin Determination Test Kit HGB S-100 & 12 (K874429) received a 510(k) decision of Substantially Equivalent on February 4, 1988, 99 days after the submission was received.

What is the product code of K874429?

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