Hemoglobin Total Linearity Control HC-110LIN

• FDA 510(k) K802568 decided 12 Nov 1980 Active
• FDA GUDID UDI-DI 00817869020175 listed 31 Jan 2019 Listed

1. 12 Nov 1980 Cleared FDA 510(k) K802568
2. 31 Jan 2019 Listed FDA GUDID 00817869020175

Trade name

Hemoglobin Total Linearity Control

Generic name

Inherited haemoglobinopathy IVD, control

Model / Ref / Catalog

HC-110LIN

Primary DI / UDI-DI

00817869020175

510(k) Number

K802568 ↗

FDA product code

KHG

GMDN term

Inherited haemoglobinopathy IVD, control

Device class

Class II

Regulation number

864.7500

GUDID distribution status

In Commercial Distribution

Category: Inherited haemoglobinopathy IVD, control

Other devices filed under FDA product code KHG (Whole Blood Hemoglobin Determination).

• OXIMETER, CO-, IL MODEL 282 by INSTRUMENTATION LABORATORY COMPANY
• KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE HB by EASTMAN KODAK COMPANY
• SERALYZER HEMOGLOBIN TEST MODULE by Miles Laboratories, Inc.
• BIOTRACK HEMOGLOBIN TEST CARTRIDGE by Biotrack, Inc.
• Cleaner 3000-6232 by EKF-diagnostic GmbH
• ABBOTT VISION HEMOGLOBIN (MODIFICATION) by Abbott Laboratories
• Hemo Control Hemoglobin Microcuvette 3000-3112-01 by EKF-diagnostic GmbH
• ERMA HB-METER MODEL 303N by Future Impex Corp.
• HEMOGLOBIN REAGENT by Anco Medical Reagents & Assoc.

• Hemoglobin G6PDH Intermediate Control HC-108IN

  Class II

  FDA 510(k) K802569 Active Cleared 12 Nov 1980 GUDID on market

• Animal Plasma Control Level II SC-113

  Class II

  FDA 510(k) K893971 Active Cleared 25 Jul 1989 GUDID on market

• ACE Calibrator SC-132

  Class II

  FDA 510(k) K930477 Active Cleared 7 Jun 1993 GUDID on market

• Whole Blood Control Level III SC-127

  Class II

  FDA 510(k) K925340 Active Cleared 23 Mar 1993 GUDID on market

See all devices from Analytical Control Systems →