FIT-CHEK

GUDID M769FITCHEK351

Fecal Immunochemical Test to screen for Colorectal Cancer.

Home Access Health Corporation

Home faecal specimen collection kit

• Primary Device ID: M769FITCHEK351
• NIH Device Record Key: 25fd3408-bb4e-4134-a0c5-6ebf80965674
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FIT-CHEK
• Version Model Number: 35
• Company DUNS: 848511283
• Company Name: Home Access Health Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M769FITCHEK351 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041408

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-04-21
• Device Publish Date: 2016-09-09

On-Brand Devices [FIT-CHEK]

• M769FITCHEK341: Fecal Immunochemical Test to screen for Colorectal cancer.
• M769FITCHEK331: Fecal Immunochemical Test to screen for Colorectal cancer.
• M769FITCHEK361: Fecal Immunochemical Test to screen for Colorectal Cancer.
• M769FITCHEK351: Fecal Immunochemical Test to screen for Colorectal Cancer.