← Back to catalogue

Easy@Home Ketone Test Strips (20 Pack)

FDA UDI

Class I (US FDA UDI)

by Easy Healthcare Corporation

Identity

Trade Name
Easy@Home Ketone Test Strips (20 Pack) FDA UDI
Generic Name
Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI
Device Name
Easy@Home Ketone Test Strips (20 Pack) FDA UDI
Model / Reference
EZR-101 FDA UDI
Description
Easy@Home Ketone Test Strips (20 Pack) FDA UDI

Identifiers

Catalog Number
EZR-101-20(P) FDA UDI
Primary DI / UDI-DI
00810038631431 FDA UDI
510(k) Number
K170587 FDA UDI
FDA Product Code
JIN FDA UDI
GMDN Term
Urine ketone IVD, kit, rapid colorimetric, clinical FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1435 FDA UDI
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

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

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: Urine ketone IVD, kit, rapid colorimetric, clinical

Easy@Home Ketone Test Strips (20 Pack) by Easy Healthcare Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Urine ketone IVD, kit, rapid colorimetric, clinical.

Cleared under the same submission

K170587 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Easy Healthcare Corporation

Sources (1)

  • FDA UDI bb058838-5420-47b9-b8d0-2dd96312c1e7 35 fields · synced Jun 8, 2026