InSure FIT 01

• FDA 510(k) K002457 decided 12 Jan 2001 Active
• FDA GUDID UDI-DI 00850093003088 listed 20 Sep 2016 Listed

1. 12 Jan 2001 Cleared FDA 510(k) K002457
2. 20 Sep 2016 Listed FDA GUDID 00850093003088

Trade name

InSure FIT

Generic name

Faecal occult blood IVD, reagent

Model / reference

01

Primary DI / UDI-DI

00850093003088

510(k) Number

K002457 ↗

FDA product code

KHE

GMDN term

Faecal occult blood IVD, reagent

Device class

Class II

Regulation number

864.6550

GUDID distribution status

In Commercial Distribution

Category: Faecal occult blood IVD, reagent

Other devices filed under FDA product code KHE (Reagent, Occult Blood).

• GASTROCCULT TM by Smithkline Diagnostics, Inc.
• HELENA COLOSCREEN SELF-TEST by Helena Laboratories, Corp.
• FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST by New Bay Bioresearch Co., Ltd.
• FORSURE IFOB DUEL SAMPLE FECAL OCCULT BLOOD TEST DEVICE (FOR PROFESSIONAL AND HOME USE); (FOR PROFESSIONAL); (FOR HOME T by Tianjin New Bay Bioresearch Co., Ltd.
• HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD by Enzo Biochem, Inc.
• ACCU-CULT FECAL OCCULT BLOOD TEST by Applied Medical Devices, Inc.
• HEMOCCULT ICT by Beckman Coulter, Inc.
• WAKO(TM) PRETEST 6A by Wako Chemicals USA, Inc.
• CAMCO R PAK-GUAIAC by Cambridge Chemical Products, Inc.
• COLONCARE by Care Products, Inc.

• InSure FIT 01

  Class II

  FDA 510(k) K101831 Active Cleared 1 Oct 2010 GUDID on market

• InSure® ONE™ 01 Open recall

  Class II

  FDA 510(k) K170548 Active Cleared 5 Oct 2017 GUDID on market

• InSure ONE Open recall

  Class II

  FDA 510(k) K170548 Active Cleared 5 Oct 2017

• !nsure Fecal Occult Blood Test

  Class II

  FDA 510(k) K002457 Active Cleared 12 Jan 2001

See all devices from Enterix Inc. →