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Fit-Chek

FDA UDI

by Home Access Health Corp.

Identity

Trade Name
FIT-CHEK FDA UDI
Generic Name
Faecal specimen collection kit IVD, home-use FDA UDI
Device Name
Fecal Immunochemical Test to screen for Colorectal Cancer. FDA UDI
Model / Reference
35 FDA UDI
Description
Fecal Immunochemical Test to screen for Colorectal Cancer. FDA UDI

Identifiers

Primary DI / UDI-DI
M769FITCHEK351 FDA UDI
510(k) Number
K041408 FDA UDI
GMDN Term
Faecal specimen collection kit IVD, home-use FDA UDI

Classification

Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Faecal specimen collection kit IVD, home-use

Fit-Chek by Home Access Health Corp. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Faecal specimen collection kit IVD, home-use.

Cleared under the same submission

K041408 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Home Access Health Corp.

Sources (1)

  • FDA UDI 25fd3408-bb4e-4134-a0c5-6ebf80965674 34 fields · synced Jun 6, 2026