AnemoCheck

FDA 510(k) K163215 · Sanguina, LLC

Substantially Equivalent

510(k) numberK163215

Submission

Device name
AnemoCheck
Applicant
Sanguina, LLC
Atlanta, GA, US
Received
November 16, 2016
Decision date
September 13, 2017
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

Other 510(k)s with product code KHG

510(k)DeviceApplicantDecision
K221508AnemoCheck HomeKHG · Traditional Sanguina, Inc.09/29/2023SE
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
K885227Clinistat Hemoglobin Reagent TestKHG · Traditional Heraeus Kulzer, Inc.02/24/1989SE

More from Heraeus Kulzer, Inc.

510(k)DeviceDecision
K221508AnemoCheck HomeKHG · Traditional 09/29/2023SE

Questions and answers

When was AnemoCheck cleared by the FDA?

AnemoCheck (K163215) received a 510(k) decision of Substantially Equivalent on September 13, 2017, 301 days after the submission was received.

What is the product code of K163215?

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