Identity
- Trade Name
- KETOCOACH METER ONLY FDA UDI
- Generic Name
- Ketone (acetoacetate) IVD, kit, spectrophotometry FDA UDI
- Model / Reference
- S11007 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860060002341 FDA UDI
- 510(k) Number
- K182593 FDA UDI
- FDA Product Code
- JIN FDA UDI
- GMDN Term
- Ketone (acetoacetate) IVD, kit, spectrophotometry 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Ketone (acetoacetate) IVD, kit, spectrophotometry
Ketocoach Meter Only by Amventurex, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ketone (acetoacetate) IVD, kit, spectrophotometry.
Cleared under the same submission
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
- Amventurex, Inc.
Sources (1)
- FDA UDI 86c0075a-0106-4015-a774-0258450946ab 33 fields · synced Jun 1, 2026