ESH, CE, (New Computer) 1341002

Trade name

ESH, "CE", (New Computer)

Generic name

Pipetting system IVD

Model / reference

1341002

Primary DI / UDI-DI

M52513410020

FDA product code

JQW

GMDN term

Pipetting system IVD

Device class

Class I

Regulation number

862.2750

GUDID distribution status

In Commercial Distribution

Category: Pipetting system IVD

Other devices filed under FDA product code JQW (STATION, PIPETTING AND DILUTING, FOR CLINICAL USE).

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• DISPENSER ASPIRATOR DA 300 by Pharmacia, Inc.
• VENTREZYME ALLERGEN DATA REDUCTION SYSTEM by Ventrex Laboratories, Inc.
• STAR I WORKSTATION by Standard Engineering
• KEMBLE 405 by Kemble Instruments, Inc.
• MINI SAMPLER PROCESSOR by Cavro Scientific Instruments, Inc.
• FIAX 420 DILUTOR by Intl. Diagnostic Technology
• AUTO PREP by Pm America, Inc.

• V8 AFSA2 Hemo Control 1812

  Class II

  FDA 510(k) K192931 Active Cleared 19 Apr 2022 GUDID on market

• V8 Nexus Hemoglobin UltraScreen 1828

  Class II

  FDA 510(k) K192931 Active Cleared 19 Apr 2022 GUDID on market

• A1AT Controls 3435

  Class I

  FDA 510(k) K213396 Active Cleared 13 Oct 2022 GUDID on market

• SPIFE A1AT Kit 552651

  Class II

  FDA 510(k) K213396 Active Cleared 13 Oct 2022 GUDID on market

See all devices from Helena Laboratories, Corp. →