Fit-Chek 35

by Home Access Health Corporation

Fit-Chek 35 is a device made by Home Access Health Corporation, cleared under FDA 510(k) K041408 on 21 Oct 2004 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI M769FITCHEK351), active as of 8 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	NumberM769FITCHEK351 UDI-DI	Date9 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK041408	Date21 Oct 2004Decided	StatusActive

Official records

FDA 510(k) database 510(k) number K041408

Across registries

2 registries list this device

FDA 510(k) K041408 decided 21 Oct 2004 Active
FDA GUDID UDI-DI M769FITCHEK351 listed 9 Sep 2016 Listed

Timeline

2 dated events

21 Oct 2004 Cleared FDA 510(k) K041408
9 Sep 2016 Listed FDA GUDID M769FITCHEK351

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Fit-Chek
Generic name: Faecal specimen collection kit IVD, home-use
Model / reference: 35

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

GUDID distribution status: In Commercial Distribution

Other devices from Home Access Health Corporation

Home Access A1C Test 84

Not classified
HIV-1 Standard Test System 21

Class III
Fit-Chek 34

Not classified
Hepatitis C Check 27

Class II

See all devices from Home Access Health Corporation →

Properties

Single use
Prescription use
Convenience kit
Lot / batch number
Expiration date

Other properties (10, all answered No)