Identity
- Trade Name
- KetoSens FDA UDI
- Generic Name
- Ketone (acetoacetate) IVD, reagent FDA UDI
- Device Name
- KetoSens B-Ketone Test Strip (individual foiled packs x 10) FDA UDI
- Model / Reference
- 276153-206 FDA UDI
- Description
- KetoSens B-Ketone Test Strip (individual foiled packs x 10) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00885325000870 FDA UDI
- 510(k) Number
- K170463 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Ketone (acetoacetate) IVD, reagent 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
No
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: Ketone (acetoacetate) IVD, reagent
KetoSens by i-SENS, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ketone (acetoacetate) IVD, reagent.
- FORA — FORA CARE INC. · Class I
- BIOCOACH Blood Ketone Test Strips 50 Pack (Foil) — AMVENTUREX, INC. · Class I
- FORA — FORA CARE INC. · Class I
- AIMTAB KETONE TABLETS — GERMAINE LABORATORIES, INC. · Class I
- ketodoc B-Ketone Test Strips (40PCS/BOX) — Rediston Limited · Class II
- keto mojo β-ketone test strips (50pcs/box) — KETO-CHECK, INC. · Class II
- KetoBM — Ketobm LLC · Class I
- bkt ß-Ketone Test Strips (100 pcs/box) — Adam Lawrence · Class II
Cleared under the same submission
K170463 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- i-SENS, Inc.
Sources (1)
- FDA UDI 3b0d3264-1f00-48fc-95ee-ec630452eb50 36 fields · synced May 30, 2026