Hemoglobin

FDA 510(k) K851432 · Pointe Scientific, Inc.,

Substantially Equivalent

510(k) numberK851432

Submission

Device name
Hemoglobin
Applicant
Pointe Scientific, Inc.,
Detroit, MI, US
Received
April 10, 1985
Decision date
July 12, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KHG – Whole Blood Hemoglobin Determination
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7500
Specialty
Hematology

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K221508AnemoCheck HomeKHG · Traditional Sanguina, Inc.09/29/2023SE
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K042379Anemiapro Self-ScreenerKHG · Traditional Biosafe Laboratories, Inc.12/15/2004SE
K020138Stat-Site MHGB Meter, Stat-Site MHGB Meter Card Holder, Stat-Site MHGB Test Cards…KHG · Special Gds Technology02/11/2002SE
K001462Careside HemoglobinKHG · Traditional Careside, Inc.08/21/2000SE
K994073Hemosite Test SystemKHG · Traditional Gds Technology, LLC01/14/2000SE
K973649Hemosite Test SystemKHG · Traditional Gds Technology, LLC08/31/1998SE
K953221Abbott Vision Hemoglobin (Modification)KHG · Traditional Abbott Laboratories09/29/1995SE
K934064Reflotron Hemoglobin Test TabsKHG · Traditional Boehringer Mannheim Corp.12/06/1993SE
K895101Biotrack Hemoglobin Test CartridgeKHG · Traditional Biotrack, Inc.10/10/1989SE

More from Biotrack, Inc.

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K061377Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional 03/28/2007SE
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K040391Total Bilirubin Reagent SetCIG · Traditional 06/02/2004SE
K031539Hemoglobin A1C Reagent SetLCP · Traditional 08/06/2003SE
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Questions and answers

When was Hemoglobin cleared by the FDA?

Hemoglobin (K851432) received a 510(k) decision of Substantially Equivalent on July 12, 1985, 93 days after the submission was received.

What is the product code of K851432?

The FDA product code is KHG – Whole Blood Hemoglobin Determination, a Class II (moderate risk) device regulated under 21 CFR 864.7500.